Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors
NCT ID: NCT00387504
Last Updated: 2013-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2006-11-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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fenretinide
4-HPR (Fenretinide) is given as a continuous intravenous infusion (CIV) for five consecutive days. Cycle is repeated every 3 weeks, if PR, CR or stable disease for 6 cycles.
pharmacological study
samples drawn per protocol
Eligibility Criteria
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Inclusion Criteria
* Tetracycline
* Nalidixic acid
* Nitrofurantoin
* Phenytoin
* Sulfonamides
* Lithium
* Amiodarone
* No concurrent total parenteral nutrition (TPN) with intralipids
* No concurrent combination antiretroviral therapy for HIV-positive patients
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
California Cancer Consortium
NETWORK
Responsible Party
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Principal Investigators
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Jacek Pinski, MD
Role: STUDY_CHAIR
University of Southern California
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, 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
City of Hope Medical Group
Pasadena, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Countries
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Other Identifiers
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CCC-PHI-54
Identifier Type: -
Identifier Source: secondary_id
NCI-7540
Identifier Type: -
Identifier Source: secondary_id
CDR0000508770
Identifier Type: -
Identifier Source: org_study_id