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Clinical Trial News Abstracts by Tom Swartz
[Editor's Note: 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 clinical trials described in this issue of ESUN, we now have over 195 clinical trials listed on our website.]
Currently Accepting Eligible Patients (not previously published in ESUN)
Post-Operative Chemoradiation for Extremity & Trunk Soft Tissue Sarcoma This Phase I trial is currently recruiting patients. The purpose of this trial is to establish the efficacy and toxicity of post-operative continuous infusion doxorubicin with concurrent external-beam radiotherapy (EBRT) in patients with extremity and trunk sarcoma. The radiation treatment and chemotherapy will start around 4-6 weeks after surgery. During the study, you will receive radiation treatments 5 days a week for 6 – 6 1/2 weeks. On Day 1 of each week of radiation therapy, you will be given doxorubicin through a continuous injection into a vein for 4 days in a row. The doxorubicin and radiotherapy will be given on an outpatient basis at M. D. Anderson. If the disease gets worse or you experience any intolerable side effects, chemotherapy and/or radiation therapy may be stopped and you may be taken off the study. At that time, your doctor will discuss other treatment options with you. Before the start of each week of treatment, you will have a physical exam and blood tests (around 2 tablespoons). You will also have a MRI to check on the status of the disease. After the study, you will have follow-up visits at M. D. Anderson every 3-4 months for the first 2 years after the study then every 6 months for the next 3 years. After that you will have follow-up visits once a year for the rest of your life to check on the status of the disease. At every follow-up visit you will have ultrasound scans. You will have a MRI at the first follow-up visit then only when the doctor feels it is necessary. Up to 30 patients will take part in this study. This trial is taking place at M.D. Anderson Cancer Center, Houston, Texas.
This Phase III trial is currently recruiting patients. The purpose of this study is to determine whether maintenance therapy with oral AP23573 (deforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo. The total expected enrollment is 650 patients. Patients 13 years of age and older with diagnosis of soft-tissue or bone sarcoma having a "favorable response" (stable disease or better) to a minimum of 4 cycles of chemotherapy (1st, 2nd, or 3rd line) are eligible. This trial is taking place at Ariad Pharmaceuticals investigational sites in Santa Monica, California, Philadelphia, Pennsylvania.
A Study of Oral PX-478 in Advanced Solid Tumors or Lymphoma This Phase I trial is currently recruiting patients. This study is being conducted to determine the safety and biologic activity of PX-478, and to allow for observation of any preliminary evidence of antitumor activity in patients with advanced metastatic cancer. The total expected enrollment is 36 patients. Patients 18 years of age and older are eligible. This trial is taking place at TGen Clinical Research Services at Scottsdale Healthcare, Scottsdale, Arizona, and M.D. Anderson Cancer Center, Houston, Texas.
Safety and Efficacy Study Using Rexin-G for Sarcoma This Phase I/II trial is currently recruiting patients. Rexin-G is being developed by Epeius Biotechnologies. It combines a targeted vector system with a proprietary mutant cell-cycle control gene (i.e. anti-cancer gene). It has been shown to eradicate remote metastatic cancers in mice and to arrest cancer growth with shrinkage and necrosis of solid tumors in humans without eliciting systemic side effects. The goal of this Phase I/II adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol. Each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. Unlike a standard Phase I protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded. Continued Rexin-G treatment will enable the targeted nanomedicine to catch up with tumor growth, halt disease progression, and reduce tumor burden. The treatment strategy is to achieve tumor control as quickly as safely possible. The total expected enrollment is 24 patients. Patients 10 years of age and older are eligible. This trial is taking place that Epeius’ Sarcoma Oncology Center, Santa Monica, California.
A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma This Phase II trial is currently recruiting patients. The primary purpose of this study is to estimate the time from the first treatment dose of LY573636 to the date your physician determines that your disease has progressed or worsened. Patients will receive a 2-hour intravenous infusion of study drug (LY573636) once every 21 days. CT-scans will be done before the first dose of study drug and then after every other treatment. The total expected enrollment is 50 patients. Patients 18 years of age and older with soft tissue sarcoma that is unresectable or metastatic are eligible. This trial is taking place at centers in California, Florida, Illinois, Kentucky, Michigan, New Mexico, New York, Oregon, Tennessee, Texas, Wisconsin, Argentina, and Spain.
Trial of Dasatinib in Advanced Sarcomas This Phase II trial is currently recruiting patients. This study will examine the response rate and the 6-month progression-free survival rates of subjects with advanced sarcoma treated with dasatinib. Subjects take Dasatinib twice daily by mouth for 28 days per 28 day cycle. Subjects will be seen for interim medical history, physical exam and laboratory studies prior to each cycle. Subjects will undergo tumor imaging every 2 months (8 weeks) for the first 6 months and approximately every 3 months thereafter while on treatment. A blood sample for collection of specimens with which to later study serum level of Dasatinib and effects on biomarkers of drug activity will be obtained approximately 2 to 4 weeks after the start of treatment. Central collection of archival tumor with which to later study the frequency of expression and/or mutation of kinases inhibited by dasatinib will occur. Subjects will be followed for approximately every 3 months until 2 years from registration and then approximately yearly until 5 years from registration. The total expected enrollment is 452 patients. Patients 13 years of age and older are eligible. This trial is taking place at centers in California, the District of Columbia, Michigan, and Pennsylvania.
This Phase I trial is currently recruiting patients. Monoclonal antibodies, such as lexatumumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. This trial is studying the side effects and best dose of lexatumumab in treating young patients with solid tumors or lymphoma that have relapsed or not responded to treatment. This is a multicenter, open-label, dose-escalation study. Patients receive lexatumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of lexatumumab 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 12 patients may be treated at the MTD, including at least 6 patients who are ≤ 12 years of age. Patients undergo blood collection periodically for pharmacokinetic studies. Blood serum is analyzed for concentration of lexatumumab via immunoenzyme techniques, for anti-lexatumumab antibodies, and for immunogenicity via flow cytometry. Previously collected tissue samples are examined by immunohistochemistry for TR1, TR2, caspase 8, survivin, and bcl-2 expression. After completion of study therapy, patients are followed periodically. A total of 36 patients will be accrued for this study. Patients between 1 and 21 years of age are eligible. This trial is taking place at NCI’s Warren Grant Magnuson Clinical Center, Bethesda, Maryland, Memorial Sloan - Kettering Cancer Center, New York, New York, and Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Study of the Safety and Pharmacokinetics of XL765 in Adults With Solid Tumors This Phase I trial is currently recruiting patients. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. The purpose of this study is to determine the safety and tolerability of XL765. It is open to patients with solid tumor that are metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival. Patients 18 years of age and older are eligible. The total expected enrollment is 63 patients. This trial is taking place at Wayne State University Karmanos Cancer Institute, Detroit, Michigan, and South Texas Accelerated Research Therapeutics, San Antonio, Texas.
Angiotensin-(1-7) in Treating Patients With Metastatic or Unresectable Solid Tumors This Phase I trial is currently recruiting patients. Angiotensin-(1-7) may stop the growth of solid tumors by blocking blood flow to the tumor. This trial is studying the side effects and best dose of angiotensin-(1-7) in treating patients with metastatic or unresectable solid tumors. This is a dose-escalation study. Patients receive therapeutic angiotensin-(1-7) subcutaneously on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of therapeutic angiotensin-(1-7) 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 during the first 3 weeks of study therapy. At least 6 patients are treated at the MTD. Blood samples are collected from patients after the first and fifth doses of the study drug for pharmacokinetic correlative studies. A total of 18 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina.
SB939 in Treating Patients With Locally Advanced or Metastatic Solid Tumors This Phase I trial is currently recruiting patients. SB939 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is studying the side effects and best dose of SB939 in treating patients with locally advanced or metastatic solid tumors. Patients receive oral SB939 once daily on days 1-5 and 15-19. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection periodically during course 1 for pharmacokinetic and pharmacodynamic studies. Samples are analyzed for levels of SB939 via LC-MS/MS method and levels of acetylated histone 3 (AcH3), target effect, downstream consequences, and tumor response via western blot, immunohistochemistry, or ELISA methods. After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter. The total expected enrollment is 30 patients. Patients 18 years of age and older are eligible. This trial is taking place at Princess Margaret Hospital, Toronto, Canada.
PR-104 in Treating Patients With Advanced Solid Tumors This Phase I trial is currently recruiting patients. This trial is studying the side effects and best dose of PR-104 in treating patients with advanced solid tumors. This is a multicenter, open-label, prospective, uncontrolled, dose-escalation study. Patients receive PR-104 IV over 60 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of PR-104 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. Blood is collected at baseline and then periodically during study treatment for pharmacokinetic and tumor marker studies. Patients undergo fludeoxyglucose F 18 positron emission tomography scanning before beginning study treatment and after completion of course 2 to assess metabolic activity of the tumor. After completion of study treatment, patients are followed at 30 days. A total of 30 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at the Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California.
Liposarcoma Tissue Procurement Protocol
The purpose
of this study is to obtain a portion of the tissue that is removed to
establish human liposarcoma tumors in a mouse model so that treatments for
this type of cancer can be studied. Participation in this study would not
affect your surgery or other treatment in any way. Your tissue will continue
to be used until the research is complete. This trial is taking place at
City of Hope Comprehensive Cancer Center, Duarte, California. Call
This observational study is currently recruiting patients. Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer and may help doctors identify patients who are at risk for cancer. This clinical trial is studying cancer risk and gene identification in patients and families with hereditary leiomyomatosis and renal cell cancer syndrome (HLRCC). Detailed family and medical histories are obtained from participants. Participants then undergo one or more of the following: physical examination, blood draw, imaging studies, and karyotypic analysis. Blood or buccal smears are examined by linkage or DNA analysis and other genetic studies. Participants may receive an explanation of study findings, appropriate counseling about their own status, and recommendations for follow-up/treatment. Participants may receive DNA results from analysis of their fumarate hydratase gene. Some participants with indeterminate renal lesions are followed every 3-36 months, depending on the characteristics (e.g., size and/or growth) of the lesion. A total of 450 participants will be accrued for this study within 3 years. There is no age limitations for participants. This trial is taking place at the NCI’s Warren Grant Magnuson Clinical Center, Bethesda, Maryland.
Not Yet Recruiting Patients (not previously published in ESUN)
There are no entries in this category for the April 2007 Issue of ESUN.
V4N5 ESUN Copyright © 2007 Liddy Shriver Sarcoma Initiative. |
