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Annotations by
Tom Swartz
mTOR Inhibitor Clinical Trials Study of AP23573, an mTOR Inhibitor, in Patients with Advanced Sarcoma This Phase II trial is currently recruiting patients. The primary objective of this study is to assess the efficacy of AP23573 in patients with advanced sarcoma when administered once daily for 5 consecutive days every two weeks. AP23573, being developed by Ariad Pharmaceuticals, Inc. The secondary objectives are to assess the safety & tolerability of this study drug regimen; to evaluate secondary efficacy endpoints, such as time to tumor progression, progression-free survival and duration of response; and to examine AP23573 blood levels and experimental parameters that may predict or indicate response to mTOR inhibition, such as effects on plasma VEGF levels and markers of tumoral PI3K/mTOR-pathway activity. The total expected enrollment for this trial is 176 patients. Patients 15 years of age and older are eligible. This trial is taking place at centers in California, Florida, Illinois, Massachusetts, Michigan, Pennsylvania, Texas, and France.
Study of Oral AP23573 to Treat Patients with Refractory or Advanced Malignancies This Phase I trial is currently recruiting patients. AP23573, being developed by Ariad Pharmaceuticals, Inc., is a mTOR inhibitor that starves cancer cells and shrinks tumors by regulating the response of tumor cells to nutrients and growth factors and by controlling tumor blood supply and angiogenesis through effects on vascular endothelial growth factor (VEGF) in tumor and endothelial cells. AP23573 is currently being studied in phase I and phase II clinical trials in patients with advanced cancers. Thus far, these trials have demonstrated that AP23573 has a favorable safety profile and possesses anticancer activity when administered as a 30-minute intravenous (IV) infusion daily x 5 every-two-weeks or on a weekly schedule. The primary objective of this current phase I trial, however, is to study the safety and tolerability of an orally administered dosage form of AP23573. This will be accomplished by an ascending dose study of 3 dosage regimens in patients with unresectable or metastatic cancer that is refractory to standard therapies. Patients 18 years of age and older are eligible. The expected total enrollment is 144 patients. This trial is taking place at the Cancer Therapy Research Center, San Antonio, Texas, and eventually at the Cancer Institute of New Jersey, New Brunswick, New Jersey.
Southern European New Drug Organization (SENDO) Foundation Trials We have been advised by Ariad that the following European trial is open to sarcoma patients. Unfortunately, we do not have a link to it. Protocols 104 and 105 are open-label, multi-center, dose escalation trials in patients with selected, advanced tumors. Centralized patient triage for enrolment and dose level assignment is coordinated by SENDO. The primary objective is to determine the maximum tolerated doses in combination with paclitaxel (PTX) in trial 104 and capecitabine (CAPE) in trial 105. Additional primary objectives include safety and pharmacokinetics profiles. The secondary objectives include efficacy endpoints and pharmacodynamic parameters.
CCI-779 and EKB-569 in Treating Patients With Advanced Solid Tumors This Phase I trial is currently recruiting patients. CCI-779 is in a class of drugs called mTOR inhibitors. EKB-569 is a new drug that inhibits the activity of the epidermal growth factor (EGF) receptor. The purpose of this trial is to study the side effects, best way to give, and best dose of CCI-779 and EKB-569 in treating patients with advanced solid tumors. This is a dose-escalation study. Patients are assigned to 1 of 3 treatment groups as follows:
In all groups, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. A total of 30-42 patients (18-30 for group I, 6 for group II, and 6 for group III) will be accrued for this study within 1.35-1.75 years. Patients 18 years of age and older are eligible. This trial is taking place at the Mayo Clinic Cancer Center, Rochester, Minnesota.
CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor This Phase II trial is currently recruiting patients. The purpose of this trial is to study how well CCI-779 works in treating patients with soft tissue sarcoma or gastrointestinal stromal tumor. Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. A total of 20-55 patients will be accrued for this study within 4-10 months. Patients 18 years of age and older are eligible. This trial is taking place at centers in the District of Columbia, Maryland, Michigan, Missouri, and Wisconsin
This Phase/II trial is open to patients with recurrent or refractory solid tumors, brain tumor, rhabdomyosarcomas, and non-rhabdomyosarcoma. The Phase I component of the study will include participants with the diagnosis of a recurrent or refractory solid tumor or brain tumor that is unresponsive to conventional therapy or with no known effective therapy. The main goal in this phase of the study is establish the maximum tolerated dose. Participants with recurrent or refractory solid tumors or brain tumors will be enrolled in this component of the study. The tolerability of the maximum dose established with solid tumors or brain tumors, will be studied in participants with recurrent or refractory leukemias. The Phase II portion of the study will look at the effectiveness of the drug. It will include two groups of participants, those with recurrent or refractory rhabdomyosarcomas and those with recurrent or refractory non-rhabdomyosarcomatous soft tissue sarcomas. Patients between 3 and 21 years old are eligible. These trials are taking place at St. Jude Children’s Research Hospital, Memphis, Tennessee.
The purpose of this study is to test the safety of the drug bevacizumab in combination with the drugs everolimus (RAD001) and erlotinib. The study will try to find the highest dose of everolimus and erlotinib that can be given in combination with bevacizumab without causing severe side effects. Bevacizumab has been approved by the U. S. Food and Drug Administration (FDA) for the treatment of advanced colorectal cancer. Erlotinib has been approved by the FDA to treat non-small cell lung cancer. Everolimus is still considered investigational, which means the FDA has not approved this drug. It is still being tested for safety and effectiveness in cancer patients. The combination of all three drugs is also considered investigational. While bevacizumab and erlotinib have been tested together in people, the combination of all three of these drugs has not been tested before. This study will be conducted in two stages. Stage I will attempt to find the highest doses of everolimus and erlotinib that can be given with bevacizumab. Stage II will use the doses found in Stage I. In stage I, the first groups of subjects will receive just bevacizumab and everolimus. Once the best doses for this combination have been determined, the next groups of subjects will receive all three drugs: bevacizumab, everolimus, and erlotinib. The best doses for all three drugs will be used in Stage II. In Stage II, half the subjects will receive everolimus alone for 14 days (Group A) before adding the other two drugs and half of the subjects will receive erlotinib alone for 14 days (Group B) before adding the other two drugs. Group assignment in stage II of the study will be randomized, meaning that it will be determined by chance. Bevacizumab will be given in the treatment room through a needle in a vein (IV infusion) once every two weeks. Erlotinib and everolimus are tablets that will be taken daily by mouth. While receiving the study drugs, you will have weekly blood tests, and you will have a physical exam every two weeks (on the days you receive Bevacizumab). An EKG will be done every 4 weeks, and you will have x-rays and scans to check your progress about every 8 weeks. Patients 18 years of age and older are eligible. This trial is taking place at Duke Comprehensive Cancer Center, Durham, North Carolina.
Miscellaneous Clinical Trials Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma This Phase II trial is currently recruiting patients. The purpose of this trial is to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma. Gefitinib (also know as Iressa) belongs to a group of anticancer drugs called epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI). Gefitinib blocks growth signals in cancer cells. These signals are caused by an enzyme called tyrosine kinase. Gefitinib blocks several of these tyrosine kinases, including one associated with Epidermal Growth Factor Receptor (EGFR). EGFR is found on the cell surface of many normal cells and cancer cells. Gefitinib works by binding to the tyrosine kinase of the EGFR to directly block growth signals turned on by triggers outside or inside the cell. Patients receive oral gefitinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. A total of 14-44 patients will be accrued for this study within 18 months. Patients 18 years of age and older are eligible. This study is taking place at centers in Belgium, France, the Netherlands, and the United Kingdom.
Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma This Phase II trial is not yet open for patient recruitment. Trastuzumab is a monoclonal antibody; it may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The purpose of this trial is to study how well trastuzumab works in treating patients with locally advanced or metastatic synovial sarcoma. Patients receive trastuzumab (Herceptin^®) IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 weeks until disease progression and then every 6 months for up to 2 years from study entry. A total of 20-40 patients will be accrued for this study within 10-40 months. Patients 18 years of age and older are eligible. The location of this trial has not yet been announced.
This Phase I study is currently recruiting patients. Filgrastim (granulocyte colony-stimulating factor) shortens the duration of chemotherapy-induced neutropenia and lowers the risk of infection. It is administered by daily subcutaneous injection after cytotoxic chemotherapy in children treated with dose-intensive chemotherapy, and has become a standard component of the treatment regimen. Filgrastim-SD/01 is a sustained duration form of Filgrastim. In phase I and phase II trials in adults, a single dose of Filgrastim-SD/01 appears to be equivalent to daily dosing of Filgrastim in enhancing neutrophil recovery and has a comparable adverse event profile. The purpose of this trial is to compare the tolerance, toxicity, and therapeutic effects of Filgrastim-SD/01 given as a single injection after chemotherapy to daily subcutaneous Filgrastim in patients with newly diagnosed Ewing’s sarcoma, rhabdomyosarcoma, and synovial sarcoma. The pharmacokinetics of Filgrastim-SD/01 will also be compared to the pharmacokinetics of Filgrastim. This trial will also be a platform for performing biological studies of these tumors and for detailed cardiac studies. High-risk patients who are treated on this front line trial and respond will also be candidates for a planned transplant protocol. A total of 34 patients (17 patients per treatment arm) will be recruited. Patients 25 years of age or less at the time of diagnosis are eligible. The location of this study is at the National Cancer Institute, Bethesda, Maryland.
FR901228 in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma This Phase II trial is currently recruiting patients. FR901228 is a type of depsipeptide and belongs to the family of drugs called histone deacetylase inhibitors. Depsipeptide binds to and inhibits histone deacetylase, thereby affecting the regulation of gene expression and inducing cell differentiation, cell cycle arrest, and apoptosis. This agent also inhibits hypoxia-induced angiogenesis and depletes several HSP90-dependent oncoproteins. The purpose of this trial is to study how well FR901228 works in treating patients with metastatic or unresectable soft tissue sarcoma. Patients receive FR901228 IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR. After completion of study treatment, patients are followed every 2 months. A total of 18-36 patients will be accrued for this study within approximately 1 year. Patients 18 years of age and older are eligible. This study is taking place at centers in Arizona, California, Georgia, Illinois, Kentucky, North Carolina, Ohio, South Carolina, and Virginia.
Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma This Phase III study is currently recruiting patients. The purpose of this study is to study the effectiveness of different regimens of combination chemotherapy with or without surgery and/or radiation therapy in treating patients with soft tissue sarcoma. This is a randomized study for patients with high-risk, nonmetastatic sarcoma. Patients are stratified according to disease type (rhabdomyosarcoma (RMS) vs. non-RMS disease) and parameningeal site of disease. Patients with RMS are further randomized by alveolar histology. Randomization occurs after the first course of chemotherapy. All patients, regardless of disease stage, are registered to this study and outcome is followed, although patients with metastatic RMS or non-RMS malignant mesenchymal tumors are referred for treatment on another study. Patients diagnosed more than 8 weeks prior to entry or who are unavailable for follow-up are not treated on study. Doses are modified for patients under 1 year of age or under 10 kg of body weight. All other patients are assigned therapy based on risk group. After surgery, patients with complete resection and with proven or possible chemosensitive histologies proceed to chemotherapy on a low-risk regimen. Patients with questionable completeness of resection proceed to chemotherapy for standard-risk or high-risk tumors, as appropriate. A total of 400 patients will be accrued for this study. Patients up to 17 years of age are eligible. The location of this study is at the Institute of Child Health, Bristol, England.
This Phase III trial is currently recruiting patients. The purpose of this trial is to compare the effectiveness of combination chemotherapy with or without hyperthermia therapy in treating patients with soft tissue sarcoma. Hyperthermia is a type of cancer treatment in which body tissue is exposed to high temperatures to damage and kill cancer cells. Patients are stratified according to risk category and disease site (extremity vs. nonextremity). Patients are randomized to one of two treatment arms. In Arm I: Patients receive etoposide IV over 30 minutes on days 1 and 4, ifosfamide IV over 60 minutes on days 1-4, and doxorubicin IV over 30 minutes on day 1. Treatment continues every 21 days for a total of 4 courses. Patients also undergo regional hyperthermia. In Arm II: Patients receive chemotherapy alone as in arm I. Patients in both arms undergo definitive surgery 4-6 weeks after chemotherapy. Patients also undergo radiotherapy beginning 4-6 weeks after surgery. After completion of surgery and radiotherapy, patients with non-resectable tumors showing no disease progression receive an additional 4 courses of chemotherapy with or without regional hyperthermia according to above treatment schedule. A total of 340 patients (170 patients per arm) will be accrued for this study. Patients 18 to 70 years of age are eligible. This study is being conducted at several centers in Germany.
This Phase III trial is currently recruiting patients. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma. Thus, the purpose of this trial is to study giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma. Patients are stratified according to WHO performance status (0 vs. 1), age group (less than 50 years of age vs. 50 years of age and over), presence of liver metastases (yes vs. no), histological grade (2 vs. 3), and participating center. Patients are randomized to 1 of 2 treatment arms as follows:
In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter. A total of 450 patients will be accrued for this study within 4 years. Patients 18 years of age to 60 years are eligible. This study is taking place at centers in Austria, Belgium, Denmark, France, Germany, the Netherlands, Slovakia, Spain, and the United Kingdom.
This Phase III trial is currently recruiting patients. It is not yet known whether surgery is more effective with or without radiation therapy. Thus, the purpose of this trial is to study surgery alone to see how well it works compared to radiation therapy together with surgery in treating patients with primary soft tissue sarcoma of the retroperitoneum or pelvis. Patients are stratified according to tumor grade (low [G1] vs. intermediate [G2] vs. high [G3/4]), tumor size (< 15 cm vs. ≥ 15 cm), and tumor histology (liposarcoma vs. non-liposarcoma). Patients are randomized to 1 of 2 treatment arms as follows:
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years. A total of 370 patients (185 per treatment arm) will be accrued for this study within 4.5 years. Patients 18 years of age and older are eligible. This study is taking place at centers in Arkansas, Colorado, the District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Missouri, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Wisconsin, and Canada.
Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma This diagnostic study is currently recruiting patients. The purpose of this study is to perform genetic testing on children with soft tissue sarcoma or rhabdomyosarcoma to identify children who are at risk of developing leukemia from the chemotherapy used to treat sarcoma. Blood is collected from patients at diagnosis (preferably before chemotherapy or transfusion), at end of therapy, and at 6 months, 1 year, 2 years, and 3 years after therapy. Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. A total of 321 patients will be accrued for this study. Patients up to 17 years of age are eligible. This is a multicenter study, which includes centers in Canada, Australia, New Zealand, Netherlands, and Switzerland.
Inhalation SLIT Cisplatin for the Treatment of Osteosarcoma Metastatic to the Lung This Phase I/II trial is currently recruiting patients. Cipslatin is a common chemotherapy agent used in treating sarcoma. Transave, Inc. is developing a new type of inhalation chemotherapy technology called sustained release lipid inhalation targeting (SLIT) which offers the potential ability to attain a prolonged therapeutic effect of cisplatin in the lung by sustained release. The ability to give SLIT cisplatin by inhalation directly to the lung permits high drug levels at the site of disease with low systemic exposure. Thus, the purpose of this trial is to determine the safety and efficacy of inhaled SLIT cisplatin administered every other week to patients with osteosarcoma who have disease that has spread to the lung. Patients will receive SLIT cisplatin by inhalation for a 14-day treatment cycle in this phase Ib/IIa, two-center, open-label, study designed to characterize the maximum tolerated dose. Clinical efficacy endpoints will be included and compared to historical controls, in addition to pharmacokinetics characterization. Efficacy will be evaluated after at least 2 cycles of therapy. Safety data, including laboratory parameters and adverse events will be collected to determine the qualitative and quantitative toxicity, and reversibility of toxicity of SLIT cisplatin. Pulmonary function tests will be performed at baseline, prior to each course and at off-study. Patients between the ages of 13 and 50 are eligible. The total expected enrollment is 21 patients. This trial is taking place at The Albert Einstein College of Medicine Montefiore Medical Center, New York, NY, and eventually Memorial Sloan Kettering Cancer Center, New York, NY.
A Study of ET 743 in Subjects With Advanced Liposarcoma or Leiomyosarcoma This Phase II trial is currently recruiting patients. The purpose of this study to test the safety and effectiveness of the investigational chemotherapy agent ET-743 in subjects with advanced liposarcoma or leiomyosarcoma. ET-743 is a cytotoxic alkaloid derived from a marine organism which covalently binds to the minor groove of DNA and may inhibit DNA replication and transcription through other mechanisms. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. Patients 18 years of age and older are eligible. This trial is taking place at centers in California, Colorado, the District of Columbia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Utah, Washington, and Wisconsin.
17-N-allylamino-17-demethoxygeldanamycin (17-AAG) Clinical Trials This Phase I study is currently recruiting patients. The purpose of this clinical trial is to study the effectiveness of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in treating young patients who have recurrent or refractory leukemia or selected solid tumors, including rhabdomyosarcoma, Ewing’s sarcoma, and osteosarcoma. Patients receive 17-AAG IV over 1 hour on days 1, 4, 8, and 11 (for patients with solid tumors) OR days 1, 4, 8, 11, 14, and 18 (for patients with leukemia). Courses for all patients repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 15 patients are treated at the MTD. Patients are followed for 30 days. A total of 70 patients (35 per stratum) will be accrued for this study within 23.3-35 months. Patients up to 21 years of age eligible. This study is being conducted at cancer centers in Arizona, Colorado, Florida, Georgia, Maryland, New York, Tennessee, and Texas.
This Phase I trial is currently recruiting patients. This phase I trial is studying the side effects and best dose of giving 17-AAG together with bortezomib in treating patients with advanced solid tumors or lymphomas. This is a dose-escalation study. Patients receive 17-AAG IV over 1 hour and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 17-AAG and bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 12 additional patients (6 patients with solid tumors and 6 patients with lymphoma) are treated as above* at the MTD. NOTE: *Bortezomib is not administered on day 1 of course 1 only. Patients are followed at 3 months. A total of 3-42 patients (3-36 with solid tumors and 6 with lymphoma) will be accrued for this study within 10.3 months-3.5 years. Patients 18 years of age and older are eligible. This trial is taking place at the Warren Grant Magnuson Clinical Center, Bethesda, Maryland and the Mayo Clinic Cancer Center, Rochester, Minnesota.
This Phase I trial is currently recruiting patients. This trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in treating patients with solid tumors that cannot be removed by surgery. This is a dose-escalation study. Patients are assigned to 1 of 2 treatment groups as follows:
Cohorts of 1-6 solid tumor patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 patients with either lymphoma or superficial solid tumors accessible for biopsy are treated as in group II at the MTD. Patients are followed for 3 months. A total of 58-130 patients (30-72 for group I and 28-58 for group II) will be accrued for this study within 2 years. Patients 18 years of age and older are eligible. This trial is taking place at the Mayo Clinic Cancer Center, Rochester, Minnesota.
This Phase I trial is currently recruiting patients. This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when given together with paclitaxel in treating patients with metastatic or unresectable solid tumor. This is a dose-escalation study of 17-AAG. Patients receive 17-AAG IV over 1 hour on days 1*, 4, 8, 11, 15 and 18 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. NOTE: *17-AAG is not administered on day 1 of course 1. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 6-12 patients are treated at the recommended phase II dose. A total of 6-35 patients will be accrued for this study within 2-11.7 months. Patients 18 years of age and older are eligible. This trial is taking place at the Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio and the Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors This Phase I trial is currently recruiting patients. This phase I trial is studying the side effects, best way to give, and the best dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when given together with gemcitabine and/or cisplatin in treating patients with advanced solid tumors. This is a dose-escalation, cohort study of 17-AAG. Patients are assigned to 1 of 3 treatment cohorts as follows: (Note: Cohort A closed to accrual as of 3/2/04; Cohort B closed to accrual as of 3/2/05).
NOTE: **Gemcitabine and cisplatin dosage is constant, while 17-AAG is escalated in cohorts B, C, and D. NOTE: ***Gemcitabine dosage is constant, 17-AAG is started at a higher dose level than all other cohorts, and cisplatin dosage is escalated in cohort E. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. In all cohorts, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed for 3 months. A total of 12 patients have been accrued for part I (cohort A closed to accrual as of 3/2/04) of this study. An additional 33-66 patients will be accrued for part II (cohorts B [closed to accrual as of 3/2/05], C, D, and E) of this study within approximately 3 years. Patients 18 years of age and older are eligible. This trial is taking place at the Mayo Clinic Cancer Center, Rochester, Minnesota.
Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors This Phase I trial is currently recruiting patients. The purpose of this trial is to study the side effects and best dose of combination chemotherapy 17-AAG and docetaxel in treating patients with metastatic or unresectable solid tumors. This is a dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). This is a dose-escalation study of 17-AAG. Patients are assigned to 1 of 2 treatment groups as follows:
Cohorts of 3-6 patients per group receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 20 additional patients (10 per group) are treated at the MTD. Approximately 33-96 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at Memorial Sloan-Kettering Cancer Center, New York, NY, and the Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.
V2N4 ESUN Copyright © 2005 Liddy Shriver Sarcoma Initiative.
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