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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 web pages 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 340 clinical trials listed on our website.]
Currently Accepting Eligible Patients (not previously published in ESUN)
Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors This Phase I trial is currently recruiting patients. Nelfinavir 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 nelfinavir in treating patients with metastatic, refractory, or recurrent solid tumors. This is a dose-escalation study. Patients receive oral nelfinavir mesylate twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may continue to receive nelfinavir mesylate. Cohorts of 3-6 patients receive escalating doses of nelfinavir mesylate 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.
Patients receive oral midazolam hydrochloride on days -2 and 20 and then undergo blood collection on days -2 and 20 for midazolam pharmacokinetics to determine CYP3A4 activity. Nelfinavir mesylate pharmacokinetics are performed on day 1 of courses 1 and 2. Patients also undergo blood collection on days 1, 8, and 42 for biological marker laboratory studies, including vascular endothelial growth factor and basic fibroblast growth factor levels as measured by enzyme-linked immunosorbent assay and phospho-Akt, total Akt, cleaved Parp, Beclin 1, p-eIF2α, LC-3, and other signal transduction markers as measured by Western blot. A total of 45 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at the Warren Grant Magnuson Clinical Center, Bethesda, Maryland.
Aflibercept in Treating Young Patients With Relapsed or Refractory Solid Tumors This Phase I trial is currently recruiting patients. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor. This trial is studying the side effects and best dose of aflibercept in treating young patients with relapsed or refractory solid tumors. This is a multicenter study.
Cohorts of 3-6 patients receive aflibercept until the maximum tolerated dose (MTD) is determined.
Blood samples are collected prior to treatment on day 1 of courses 1, 2, and 5 or 6 for pharmacokinetic studies. After completion of study treatment, patients are followed for at least 30 days. The estimated enrollment is 27 patients. Patients between 1 and 21 years of age are eligible. This trial is taking place at centers in Alabama, California, Illinois, Indiana, Ohio, Tennessee, Texas, and Washington.
A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen This Phase I trial is currently recruiting patients. This is a phase 1, open label, multiple dosing, single arm study. Each patient will be enrolled to receive MBV subcutaneously at the starting dose of 250 EU (1 µL) twice weekly. In the absence of a dose-limiting toxicity (DLT, the MBV dose will be escalated in each patient to the MBV dose level that elicits a body temperature of 38C -39.5C or up to the maximum dose level 8. Once the desired pyrogenic effect is reached, patients will then be given MBV twice weekly for 4 doses at the pyrogenic dose level. For patients not achieving the desired pyrogenic effect at dose level 8, no additional MBV will be administered. Vaccination will be administered twice weekly on Monday and Thursday of each week.
During each vaccination clinic visit, patients will be observed up to 6 hours post vaccination and vital signs will be measured hourly. At baseline, and throughout the study period, patients will be assessed for NY-ESO-1 specific humoral and cellular immunity, chemistry, hematology and cytokine analysis for IL-1, IL-6, IFNgamma, and TNF-alpha. Toxicity assessments will be made throughout the study. The estimated enrollment is 12 patients. Patients 18 years of age and older are eligible. This trial is taking place at the Ludwig Institute for Cancer Research, Frankfurt, Germany.
ABT-888, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Cancer This Phase I trial is currently recruiting patients. ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with carboplatin and paclitaxel may help kill more tumor cells. This trial is studying the side effects and best dose of ABT-888 when given together with carboplatin and paclitaxel in treating patients with advanced solid cancer. Patients receive escalating doses of oral ABT-888 twice daily on days 1-7 (beginning in course 2) in combination with carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 3. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Peripheral blood mononuclear cells are collected on day 1 of course 1 and days 1 and 3 of course 2 for pharmacokinetic studies, evaluation of DNA adducts, and Poly-ADP ribose (PAR) levels. After completion of study treatment, patients are followed for 4 weeks. The estimated enrollment is 30 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in California and Pennsylvania.
A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered as a Single Agent This Phase II trial is currently recruiting patients. This multicenter, open-label, study will enroll approximately 185 patients with metastatic or advanced sarcoma, to assess the efficacy and tolerability of IMC-A12 monotherapy. The patient population will be stratified into five tiers according to diagnosis: Ewing's sarcoma/PNET; rhabdomyosarcoma; leiomyosarcoma; adipocytic sarcoma; synovial sarcoma. A total of 85 patients will be enrolled initially, 17 in each tier. Patients will receive single agent IMC-A12 as a 10 mg/kg intravenous (I.V.) infusion over 1 hour every 2 weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation every cycle. The Simon two-stage design will be applied separately to each tier; safety and response in the initial 17 patients in each tier will be used to determine whether to extend enrollment to the target total of 37 patients per tier (for a total of 185 subjects). Patients 12 years of age and older are eligible. This trial is taking place at MD Anderson Cancer Center Orlando, Florida.
Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas This Phase II trial is currently recruiting patients. The purpose of this study is to assess the short term and the long term side effects of proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas. Participants will receive radiation treatments once per day, 5 days a week for a total of 4 to 6 weeks, depending on how much total dose the tumor requires. The radiation doctor will see the participant once each week to monitor and record any side effects they may have from radiation treatment. A special device will be made for each participant to help them hold still during the treatment. This may either be a mask or foam cradle, depending on the area to be treated. The estimated enrollment is 30 patients. Patients up to 30 years of age are eligible. This trial is taking place at Massachusetts General Hospital and Dana-Farber Cancer Institute, Boston Massachusetts.
AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma This Phase II trial is currently recruiting patients. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is studying how well AZD0530 works in treating patients with recurrent locally advanced, or metastatic soft tissue sarcoma. This is a multicenter study. Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 8 weeks. The estimated enrollment is 37 patients. Patients 18 years of age and older are eligible. This trial is taking place at the Fox Chase Cancer Center, Philadelphia, Pennsylvania, and at centers in Canada.
Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors This Phase I trial is currently recruiting patients. Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. This trial is studying the side effects and best dose of fenretinide in treating patients with metastatic or unresectable malignant solid tumors. This is a dose-escalation, multicenter study.
Patients receive fenretinide IV continuously on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete or partial response may continue to receive fenretinide at the discretion of the study chair. Cohorts of 3-6 patients receive escalating doses of fenretinide 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. At least 6 patients are treated at the MTD. Patients undergo blood sample collection to determine plasma concentrations (pharmacokinetics) of fenretinide periodically during course 1 and at the end of courses 2-6. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. A total of 21 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at centers in California.
Not Yet Recruiting Patients (not previously published in ESUN)
No entries in this category this issue
V5N3 ESUN Copyright © 2008 Liddy Shriver Sarcoma Initiative.
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