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Clinical Trial News Annotations by Tom Swartz
[Editor's Note: We made a substantial change in mid-October 2006 in the way in which we are providing clinical trial information in ESUN and on our website. Although these changes were described in the October issue of ESUN, we think they should be mentioned one more time. Because the Clinical Trial News column is so highly accessed, we have reduced the need for you to "search" back issues of ESUN to locate clinical study information. We have created three separate webpages where all of the clinical trial information that we have published in ESUN to date has been collected. You can read about these changes in the editorial, Changes Made, in the October 2006 issue of ESUN. With the addition of the 15 clinical trials described in this issue of ESUN, we now have over 165 clinical trials listed on our website.]
Currently Accepting Eligible Patients (not previously published in ESUN)
Collection of Alveolar Soft Part Sarcoma Tumor Specimens for Research This observational study is currently recruiting patients. This study will collect tumor specimens from patients undergoing surgical treatment for alveolar soft part sarcoma (ASPS). This rare, slow-growing cancer originates in soft connective tissues of the body. It most often first appears in the thigh or legs, but may originate in the head and neck. ASPS can metastasize (spread) to other areas of the body, such as the lungs or brain, many years after it is diagnosed. The disease is resistant to standard anti-cancer drugs and radiation treatment; currently, the most widely accepted treatment is repeated surgery to remove tumors as they develop in multiple sites. Patients of any age who are undergoing surgery for primary or metastatic ASPS are eligible to participate in this study. Participants give permission for study investigators to use tumor tissue removed during their surgery for research purposes. The tumor specimens will be used to establish cell lines that will allow researchers to study the cell biology of this unusual tumor, possibly leading to new treatment approaches. Patients 4 years of age and older are eligible. This trial is coordinated by the National Cancer Institute (NCI), Bethesda, Maryland.
Phase II Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas This Phase II trial is currently recruiting patients. This is a study of perifosine in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg orally qhs with food until disease progression. Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food. Administering the drug qhs has been shown to decrease gastrointestinal toxicity in some patients. Patients may need anti-emetics and/or anti-diarrheals. All patients may continue therapy unless disease progression is documented on two occasions at least 4 weeks apart. Patients who experience toxicity may continue on treatment with doses delayed or reduced. Evaluation of all lesions for progression or response will be made at 3-month intervals. Treatment will be administered on an outpatient basis in 28-day cycles. The total expected enrollment is 111 patients. Patients 13 years of age and older are eligible. This trial is taking place at Century City Sarcoma Oncology Center, Santa Monica, California and MD Anderson Cancer Center, Houston, Texas.
This Phase II trial is currently recruiting patients. Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells. This trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma. Patients are stratified according to resectability of the primary tumor (recurrent, refractory, or very high-risk disease vs. unresectable primary tumor).
NOTE: *Patients who have undergone PBSC collection before study entry proceed to high-dose samarium Sm 153 lexidronam pentasodium (153Sm-EDTMP) infusion without mobilization and collection of autologous PBSCs.
NOTE: **Patients may receive the trace dose on protocol JHOC-J0094.
A total of 54 patients will be accrued for this study. Patients between 15 and 30 years of age are eligible. This trial is taking place at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.
Bevacizumab and Radiation Therapy for Sarcomas This Phase II trial is currently recruiting patients. The main purpose of this study is to test the effectiveness of bevacizumab in combination with radiation therapy to see what effects (good or bad) they have on patients with soft tissue sarcoma. Bevacizumab is an antibody designed specifically to slow or stop the growth of cancerous tumors by decreasing the blood supply to the tumor. Bevacizumab is approved by the FDA in combination with intravenous 5-fluorouracil-based chemotherapy as a treatment for patients with cancer of the colon or rectum that has spread. However, the use of bevacizumab in combination with radiation for sarcomas is still under investigation. The dose of bevacizumab and radiation therapy will be the same for all participants throughout the study. Bevacizumab will be given as an intravenous infusion every 2 weeks for a total of 4 doses. Radiation therapy will begin 2 weeks after the first bevacizumab infusion and will be delivered 5 days per week over a period of 6 weeks. This is done as an outpatient procedure. Each 2 week period will be considered a separate treatment cycle. Participants will be treated with radiation therapy for a maximum of 3 cycles (6 weeks). A surgeon will evaluate the participant’s tumor by radiologic studies before study treatment to determine if surgical removal is possible. After the completion of study treatment, a surgeon will repeat the evaluation of the tumor. Surgery will performed 6-7 weeks after the completion of radiation therapy. The total expected enrollment is 28 patients. Patients 18 years of age and older are eligible. This trial is taking place at Massachusetts General Hospital, Boston, Massachusetts.
This Phase I trial is currently recruiting patients. Drugs used in chemotherapy, such as talabostat, temozolomide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. This trial is studying the side effects and best dose of talabostat when given together with temozolomide or carboplatin in treating young patients with relapsed or refractory brain tumors or other solid tumors, including sarcomas. This is a dose-escalation study of talabostat. Patients are stratified according to tumor histology and prior therapy. Based on stratification, patients receive either oral temozolomide on days 1-5 or carboplatin IV over 30 minutes on days 1-2. Patients also receive oral talabostat on days 7-20. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 2-6 patients receive escalating doses of talabostat until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or < 4 of 12 patients experience dose-limiting toxicity during the first course of therapy. A total of 24 patients will be accrued for this study. Patients between 2 and 18 years of age are eligible. This trial is taking place at the Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland.
This Phase I trial is currently recruiting patients. Rapamycin is a drug that has been approved by the Food and Drug Administration (government) for use in patients receiving a kidney transplant to prevent the patient’s body from rejecting the transplanted kidney. It has shown antitumor effects in the laboratory, but has not been approved at this time for the treatment of cancer. Abraxane is a new form of chemotherapy that has been approved by the Food and Drug Administration for the treatment of metastatic breast cancer, and is a promising drug that is being evaluated in clinical trials for treatment of other cancers. This study is designed to find out if different doses of Rapamycin, when combined with Abraxane, are safe and well tolerated. The trial is open to patients with advanced solid tumors. For patients with tumors other than breast cancer, they must be refractory to standard therapy or for which no curative standard therapy exists, to be considered. Metastatic disease, if present, should not be progressing so as to require palliative treatment within 4 weeks of enrollment based on clinical assessment by the investigator. The total expected enrollment is 24 patients. Patients 18 years of age and older are eligible. This trial is taking place at the Yale Comprehensive Cancer Center at Yale University School of Medicine, New Haven, Connecticut.
This Phase I trial is currently recruiting patients. Gene therapy may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. This trial is studying the side effects and best dose of gene therapy together with chemotherapy in treating patients with advanced solid tumors or non-Hodgkin's lymphoma. This is a dose-escalation study of CD34 stem cells and carmustine. After a negative bone marrow sampling, patients receive sargramostim (GM-CSF) and filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-5 (or G-CSF twice daily alone for 4-5 days). Peripheral blood progenitor cells are collected 24 hours after the last dose of growth factor injection on day 5 and also on day 6, if necessary. The CD34 positive stem cells are then infected by the retroviral mutant MGMT-G156A ex vivo. Patients receive O6-benzylguanine (BG) IV over 1 hour followed by carmustine IV over 1 hour every 6 weeks for 5 courses, assuming recovery of peripheral blood counts. Approximately 72 hours after the end of the first course of chemotherapy, patients receive reinfusion of retrovirally-transduced hematopoietic stem cells over 5-10 minutes. Four weeks after the completion of BG and carmustine, patients receive BG IV over 1 hour followed by temozolomide IV over 1 hour every 4 weeks for up to 5 courses, in the absence of hematologic toxicity. Patients with responding disease may continue to receive BG and temzolomide in the absence of disease progression or unacceptable toxicity provided other phase II studies indicate the safety of more than 5 courses. Cohorts of 3-6 patients receive escalating numbers of CD34 stem cells targeted for retroviral infection and escalating doses of carmustine. Patients are followed monthly for 2 months, every 4 months for 8 months, and then every 6 months thereafter. A total of 12-18 patients will be accrued for this study. Patients between 18 and 70 years old are eligible. This trial is taking place at the Case Comprehensive Cancer Center, Cleveland, Ohio.
Phase I Abraxane With Gemcitabine in Solid Tumors This Phase I trial is currently recruiting patients. Abraxane™ is a protein-bound form of the popular chemotherapy drug paclitaxel (brand name Taxol®). Standard paclitaxel is formulated with ethanol and a substance called Cremophor EL (polyoxyethylated castor oil) in order to improve drug delivery. However, these additives are felt to contribute to the side effects associated with paclitaxel, thereby increasing the potential need for dose reduction and reducing patients' quality of life. Furthermore, Cremophor EL may cause some of the hypersensitivity reactions that occur in 25-50% of patients during infusion and that require preventive steroid premedication. To make matters worse, ethanol and Cremophor EL leach plasticizers from PVC bags and infusion sets, requiring preparation and administration of paclitaxel in glass bottles or non-PVC infusion systems. In Abraxane the protein that is complexed with it is albumin, a naturally occurring, blood-soluble protein. Abraxane is Cremophor-free, and was developed to help alleviate the side effects of paclitaxel. Also, Abraxane achieves a higher concentration of paclitaxel in solution, resulting in decreased infusion volume and time, and no need for non-standard infusion sets. Albumin is an ideal protein to deliver the taxane to tumor cells, as it is well-tolerated and large in size, and many solid tumors have an affinity for binding albumin and thus may help accumulate Abraxane inside tumors increasing the effectiveness of standard paclitaxel. Thus the purpose of this trial is to determine the maximum tolerated dose of Abraxane in combination with gemcitabine. The gemcitabine dose will remain 1000 mg/m2 on days 1, 8 every 21 days, and the Abraxane dose will be escalated based on the presence or absence of dose limiting toxicities. Six to fifteen patients with histologically or cytologically documented solid tumors will be enrolled. Patients 18 years of age and older are eligible. This trial is taking place at the University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.
Radiation Therapy to Treat Musculoskeletal Tumors This Phase II trial is currently recruiting patients. Researchers at St. Jude Children’s Research Hospital are looking for more effective ways to deliver radiation therapy to pediatric tumors of the bone and soft tissues. The goal of the study is to improve local control of musculoskeletal tumors with image-guided radiation therapy (IGRT) while minimizing radiation related side effects. IGRT uses computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) images to precisely define tumor location and to carefully plan radiation treatment. This approach allows doctors to deliver highly conformal radiation therapy to the tumor while protecting nearby healthy normal tissues. The total expected enrollment is 100 patients. Patients up to 25 years of age are eligible. This trial is taking place at the St. Jude Children's Research Hospital, Memphis, Tennessee.
A Phase 1 Study of ARQ 171 in Patients With Advanced Solid Tumors This Phase I trial is currently recruiting patients. This is an open label, dose escalation study of ARQ 171 administered via intravenous infusion (IVI) into a peripheral vein weekly. Patients with advanced solid tumors which are refractory to available therapy or for whom no standard systemic therapy exists are eligible. The total expected enrollment is 30 patients. Patients 18 years of age and older are eligible. This trial is taking place at Premiere Oncology, Santa Monica, California; contact: Ana Maria Silva, RN, MSN 310-633-8400.
This Phase I trial is currently recruiting patients. Sodium stibogluconate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon may interfere with the growth of cancer cells. Giving sodium stibogluconate together with interferon may kill more cancer cells. This trial is studying the side effects and best dose of sodium stibogluconate when given together with interferon in treating patients with advanced solid tumors, lymphoma, or myeloma. This is an open-label, dose-escalation study of sodium stibogluconate (SSG). Patients receive SSG IV over 15 minutes on days 1-5, 8-12, 15-19, and 22-26 and interferon alfa-2b subcutaneously daily on days 2-26. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of SSG 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. A total of 24 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at the Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio.
Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer This Phase II trial is currently recruiting patients. Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. This trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer (uterine carcinosarcoma). This is a non-randomized, multicenter study. Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. A total of 22-60 patients will be accrued for this study within 1-4 years. Patients of any age are eligible. This trial is taking place at centers in Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Iowa, Louisiana, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin.
This unspecified phase trial is currently recruiting patients. Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that cannot be removed by surgery. This clinical trial is studying how well cryotherapy works in treating patients with primary lung cancer or lung metastases that cannot be removed by surgery. Patients undergo CT-guided percutaneous thoracic cryotherapy over 2 hours under local or general anesthesia. Grouped cryoprobes are inserted into the tumor, utilizing a freeze-thaw-freeze cycle, creating cytotoxic temperatures (less than -20°C to -40°C) that encompass the entire anticipated tumor volume. Patients undergo positron emission tomography at baseline and after cryotherapy to assess tumor standard uptake variable. After completion of study treatment, patients are followed at 1, 3, 6 and 12 months. A total of 40 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at the Barbara Ann Karmanos Cancer Institute, Detroit, Michigan.
Not Yet Recruiting Patients (not previously published in ESUN)
Temsirolimus, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Tumors This Phase I trial is not yet open for patient recruitment. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving temsirolimus together with chemotherapy may kill more tumor cells. This trial is studying the side effects and best dose of temsirolimus, carboplatin, and paclitaxel in treating patients with advanced solid tumors. This is a multicenter, open-label, dose-escalation study. The treatment outline is as follows.
In each part, treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients in part B also undergo blood collection periodically for pharmacokinetic studies. In each part, cohorts of 3-6 patients receive escalating doses of temsirolimus, carboplatin, and paclitaxel 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. The recommended phase II dose (RPTD) is the dose that is one dose level below the MTD. Once the RPTD is determined in part A, patients begin entry in part B. Up to 10 patients with endometrial or ovarian cancer are treated at the RPTD determined in part B of the study. After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter. A total of 30 patients will be accrued for this study. Patients 18 years of age and older are eligible. The location of this trial has not yet been identified.
Treatment With MK6592 and an Anti-Cancer Drug in Patients With Advanced Solid Tumors This Phase I trial is not yet open for patient recruitment. The purpose of this trial is to evaluate the safety and tolerability of MK6592 in combination with an anti-cancer drug in adult patients with advanced solid tumors. This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants). Further study details as provided by Merck. Patients with advanced solid tumors (metastatic or local) unresponsive to standard therapy, progressed on standard therapy, or for whom no standard therapy exists are eligible. There is no limit to the number of prior treatment regimens. Patients 18 years of age and older are eligible. The location of this trial is not identified. For further information call: 1-888-577-8839.
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