Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors

NCT00387504 | Completed Phase 1

• 4 other identifiers: CDR0000508770U01CA062505CCC-PHI-54NCI-7540
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 7

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

fenretinide DRUG

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 OTHER

samples drawn per protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor malignancy * Metastatic and/or unresectable disease * No standard curative or palliative measures exist or remain effective * Measurable or evaluable disease * No known brain metastases unless previously resected or irradiated with no treatment with steroids for more than 1 month PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 or Karnofsky PS 60-100% * Life expectancy \> 3 months * WBC ≥ 3,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 75,000/mm³ * Bilirubin \< 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN (5 times ULN for patients with known liver metastases) * Creatinine normal OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception prior to, during, and for ≥ 6 months after completion of study treatment * No uncontrolled diabetes mellitus at high risk for hypertriglyceridemia (i.e., fasting serum glucose concentration \> 200 mg/dL OR hemoglobin A1C \> 7.5%) * No egg allergy * No history of allergic reactions to compounds of similar chemical or biologic composition to fenretinide (e.g., isotretinoin, vitamin A, or tretinoin) * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situation that would preclude compliance with study requirements * No known hypertriglyceridemia requiring medication * No identified familial hyperlipidemia disorder PRIOR CONCURRENT THERAPY: * Recovered from all prior therapy * Prior treatment with oral fenretinide is allowed provided no severe toxicity occurred * At least 2 weeks since prior major surgery * More than 4 weeks since prior chemotherapy or radiotherapy * At least 6 weeks since prior nitrosoureas or mitomycin C * No other concurrent investigational agents * No other concurrent anticancer chemotherapy * No other concurrent antioxidants\* * No concurrent hormone-ablative agents, including steroids, except for adrenal replacement or anti-inflammatory indications * No other concurrent anticancer agents or therapies * No concurrent herbal or other alternative therapies\* * No concurrent vitamin supplements (e.g., vitamin A, ascorbic acid, or vitamin E)\* * Standard-dose multivitamin allowed * No other concurrent medications that may act as modulators of intracellular ceramide levels or ceramide cytotoxicity, sphingolipid transport, p-glycoprotein, multidrug resistance protein 1 (MRP1), or MRP1 drug/lipid transporters, including any of the following\*: * Cyclosporine or any of its analogues * Verapamil * Tamoxifen or its analogue * Ketoconazole * Chlorpromazine * Mifepristone * Indomethacin * Sulfinpyrazone NOTE: \*Patients who have discontinued these drugs for ≥ 1 week are eligible * No concurrent medications that may cause pseudotumor cerebri, including any of the following: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• California Cancer Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Childrens Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553, United States

Location

City of Hope Medical Group

Pasadena, California, 91105, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Interventions

Fenretinide

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Jacek Pinski, MD

  University of Southern California

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: November 1, 2006
• Primary Completion: July 1, 2013
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

US (7)