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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 300 clinical trials listed on our website.]
Currently Accepting Eligible Patients (not previously published in ESUN)
This Phase I trial is currently recruiting patients. Monoclonal antibodies, such as IMC-A12, 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 IMC-A12 in treating young patients with relapsed or refractory Ewing sarcoma/peripheral primitive neuroectodermal tumor or other solid tumors. This is a multicenter study. Patients are stratified according to disease (refractory solid tumors [stratum 1] vs. Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET) [stratum 2 - accrual to this stratum will be restricted to patients ≥ 12 years of age until safety is determined in stratum 1; then accrual will continue for patients of all ages]). Patients receive IMC-A12 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 4 weeks for up to 2 years in the absence of unacceptable toxicity or disease progression. Patients undergo blood sample collection periodically for pharmacokinetic, immunogenicity, and other correlative studies. Samples are analyzed for serum levels of IGF-I, IGF-II, IGF-BP3, growth hormone, insulin, and C-peptide; trough concentrations and PK sampling; and biomarkers, including IGF-IR expression and phosphorylation and insulin receptor expression and phosphorylation via immunoprecipitation and Western immunoblotting. Tumor tissue samples from patients with Ewing sarcoma/peripheral PNET are banked for future research. After completion of study treatment, patients are followed at 30 days. The estimated enrollment is 48 patients. Patients between 1 and 21 years of age are eligible. This trial is taking place at centers in Alabama, California, the District of Columbia, Missouri, Ohio, Oregon, and Texas.
This Phase I trial is currently recruiting patients. Dichloroacetate (DCA) is a small molecule that has been used for years to treat lactic acidosis and rare metabolic disorders in humans. Further testing now shows that it may suppress the growth of human cancer cells. Tests of DCA on human cells cultured outside of the body have found that it killed lung, breast, and brain cancer cells, without affecting human normal cells. Tumors in rats that were infected with human tumors also shrank considerably. Most cancers are characterized by a resistance to apoptosis (cell death that removes abnormal cells) that makes them more likely to grow as well as be resistant to most cancer treatments. Plus, many current cancer treatments kill both cancerous and healthy cells and are highly toxic. DCA works by reversing the damage to the mitochondria that is present in cancer cells, thus reactivating the apoptosis (cell death) mechanism in them. The result is the death of the cancer cells. This mitochondrial reactivation presents an entirely new approach to treating cancer. DCA is known to be relatively well tolerated with few significant side effects and its selectivity, effectiveness and ease of delivery (oral) make it an attractive opportunity. It is hoped that one day this treatment may become a safe and effective treatment, either along or in conjunction with other treatments, for many forms of cancer. The purpose of this trial is to (1) assess safety and tolerability of oral DCA; (2) determine the dose-limiting toxicity and phase II dose; and (3) characterize DCA’s pharmacokinetic profile. It is open to patients with histologically or cytologically confirmed recurrent or metastatic solid tumors with no meaningful therapies available. Patients 18 years of age and older are eligible. This trial is taking place at the Cross Cancer Institute, Edmonton, Canada.
LBH589, Paclitaxel, Carboplatin +/- Bevacizumab for Solid Tumors This Phase I trial is currently recruiting patients. This trial will evaluate the safety and tolerability of the combination of LBH589 and paclitaxel/carboplatin in patients with solid tumors. The combination of LBH589, paclitaxel/carboplatin, and bevacizumab will also be evaluated for tolerability and preliminary antitumor activity in a subset of patients with advanced non-small cell lung cancer.
The estimated enrollment is 40 patients. Patients 18 years of age and older are eligible. This trial is taking place at Tennessee Oncology, PLLC, Nashville, Tennessee.
LBH589 and Gemcitabine in the Treatment of Solid Tumors This Phase I trial is currently recruiting patients. This will be a single center phase I dose escalation trial. LBH589 will be administered orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days. Dose escalation will begin at Dose Level 1. Three patients will be enrolled at each dose level. If 1/3 patients experiences dose-limiting toxicity, the dose level will be expanded to 6 patients. If 2/6 patients experience dose-limiting toxicity at a specific dose level, then the previous dose level will be considered the recommended phase II dose. Dose escalation will continue until the maximum tolerated dose is determined or until all dose levels outlined in the protocol have been completed. A total of 10 patients will be treated at the dose that is recommended for further phase II evaluation to further assess the safety of the combination regimen. Toxicity assessments will be ongoing and disease assessments will be repeated every 2 treatment cycles. Patients will be allowed to continue on study until disease progression unless toxicity warrants drug discontinuation. The estimated enrollment is 40 patients. Patients 18 years of age and older are eligible. This trial is taking place at Tennessee Oncology, PLLC, Nashville, Tennessee.
A Study of R1507 in Patients With Recurrent or Refractory Sarcoma This Phase II trial is currently recruiting patients. R1507 is a human monoclonal antibody designed to inhibit (turn off) tumor growth. This single arm study will evaluate the efficacy and safety of R1507 in patients with recurrent or refractory sarcoma. Five cohorts of sarcoma patients will be studied in parallel: Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma, and other sarcomas. All patients will receive R1507 9mg/kg by IV weekly. The anticipated time on study treatment is until disease progression or unacceptable adverse events, and the target sample size is 100-500 individuals. Patients 12 years of age and older are eligible. This trial is taking place at 62 locations worldwide (not all currently recruiting).
R1507 in Patients With Recurrent or Refractory Sarcomas This Phase II trial is currently recruiting patients. R1507 is a human monoclonal antibody designed to inhibit (turn off) tumor growth. The primary objectives of this trial are to: (1) determine the overall objective response rate of R1507 in patients with recurrent or refractory osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas of the following subtypes: alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma; and (2) determine the progression-free survival at 18 weeks from start of treatment of patients with progressive, recurrent or refractory Ewing's sarcoma. Patients will receive 9 mg/kg of R1507 by IV weekly Over 60 Minutes. The estimated enrollment is 245 patients. Patients 12 years of age and older are eligible. This trial is taking place at centers in Washington, D.C., Michigan, Pennsylvania, Texas, France, and the United Kingdom.
This Phase II trial is not yet recruiting patients. This study will assess the safety and efficacy of a combination of Avastin and standard chemotherapy, compared with standard chemotherapy alone, in childhood and adolescent patients with metastatic rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) or Ewing's sarcoma/soft tissue primitive neuroectodermal tumors (ET/PNET). Patients will be randomized to receive Avastin + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy, +/- Avastin 7.5mg IV on day 1 of each cycle) followed by 4-week cycles of maintenance treatment (standard chemotherapy, +/- Avastin 5mg/kg IV on days 1 and 15 of each cycle). A safety analysis will be carried out after the first 44 patients have completed 6 cycles of treatment, before further patients are recruited. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Patients between 2 and 17 years of age are eligible. This trial will take place at centers in France, Italy, the Netherlands, and the United Kingdom.
This Phase II trial is currently recruiting patients. Drugs used in chemotherapy, such as vincristine, topotecan, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop tumor growth by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. This randomized phase II trial is studying giving vincristine together with topotecan, and cyclophosphamide to see how well it works compared with giving vincristine together with topotecan, cyclophosphamide, and bevacizumab in treating young patients with refractory or first recurrent extracranial Ewing's sarcoma. Patients are stratified according to time to disease recurrence (< 2 years vs. ≥ 2 years).
After completion of study therapy, patients are followed periodically. The estimate enrollment is 78 patients. Patients between 1 and 29 years of age are eligible. This trial is taking place at the Stanford Cancer Center, Stanford, California, the Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut, Farmington, Connecticut, Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio.
This Phase I/II trial is currently recruiting patients. This multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma. The estimated enrollment is 90 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in California, Massachusetts, Pennsylvania, Austria, Belgium, France, and the Netherlands.
A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. (SPRAY) This Phase II trial is currently recruiting patients. The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex® in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy. The estimated enrollment is 336 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in Arizona, California, Maryland, North Carolina, Ohio, and Texas.
Currently Accepting Eligible Patients (not previously published in ESUN)
No entries in this category this issue
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