Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00387504
- Lead Sponsor
- California Cancer Consortium
- Brief Summary
RATIONALE: 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.
PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide in treating patients with metastatic or unresectable malignant solid tumors.
- Detailed Description
OBJECTIVES:
* Determine the maximum tolerated dose of fenretinide in patients with metastatic or unresectable malignant solid tumors.
* Determine the toxic effects of this drug in these patients.
* Determine the pharmacokinetics and in vivo activity of this drug in these patients.
* Determine, preliminarily, disease or tumor response in patients treated with this drug.
OUTLINE: 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.
PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) of fenretinide at end of study Toxicity as measured by type (organ affected or laboratory determination such as absolute neutrophil count), severity (NCI CTCAE v3.0), time of onset (course number), duration, and reversibility or outcome ongoing Survival and time to failure as measured by Kaplan-Meier at end of study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
City of Hope Medical Group
🇺🇸Pasadena, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Texas Tech University Health Sciences Center
🇺🇸Lubbock, Texas, United States
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Contra Costa Regional Medical Center
🇺🇸Martinez, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States