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Phase I Evaluation of Fenretinide (NSC# 374551)

Phase 1
15 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Evaluation of Fenretinide (NSC# 374551)

OBJECTIVES: I. Determine the maximum tolerated dose and toxicity of oral fenretinide in
patients with solid malignant tumors. II. Determine the pharmacokinetics of fenretinide and
its metabolites. III. Determine the preliminary antitumor activity of fenretinide in this
patient population. IV. Determine the recommended phase II starting dose of fenretinide. V.
Determine whether fenretinide induces apoptosis in clinical specimens.

OUTLINE: This is a dose escalation study. Patients receive oral fenretinide once daily on
days 1, 8 and 9 and three times a day on days 2-7. Courses repeat every 3 weeks in the
absence of disease progression or unacceptable toxicity. Treatment continues for up to 6
months following complete remission. Accessible tumors are biopsied on day 8. 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.

PROJECTED ACCRUAL: Approximately 21 patients will be accrued for this study within 6-9

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven solid malignant tumors (carcinoma or
sarcoma) Not eligible for any known treatment or regimen of higher potential efficacy No
history of CNS tumors or prior CNS metastases

PATIENT CHARACTERISTICS: Age: 15 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/mL SGOT/SGPT no greater
than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/mL OR
Creatinine clearance at least 60 mL/min Cardiovascular: At least 6 months since any acute
myocardial infarction No congestive heart failure No New York Heart Association class III
or IV heart disease No clinically significant cardiac arrhythmias Pulmonary: Not specified
Other: Not pregnant or nursing Fertile patients must use effective contraception No
gastrointestinal bleeding or bleeding tendency

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy (at least 6 weeks since nitrosoureas or mitomycin) and recovered
No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks
since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified
Other: No prior systemic retinoid therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Patricia M. LoRusso, DO

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

May 1998

Completion Date:

December 2008

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201