Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Fenretinide

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) after platinum-containing chemotherapy regimen with or without thoracic radiotherapy

• Limited stage or extensive stage SCLC

• Measurable disease

• At least 20 mm by conventional techniques OR

• At least 10 mm with spiral CT scan

• No pleural effusions, bone metastases, brain metastases, or abnormal radionucleotide scans as sole evidence of disease

• No symptomatic or uncontrolled brain or leptomeningeal disease

• Previously treated brain metastases allowed if neurologically stable

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-2

Hematopoietic:

• WBC at least 2,500/mm^3

• Platelet count at least 70,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• SGOT no greater than 2 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No symptomatic heart disease

• No myocardial infarction within the past 6 months

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception for 1 month before, during, and for 2 months after study

• No pre-existing retinal degenerative disease (e.g., retinitis pigmentosa or associated disorders)

• No other serious concurrent illness

• No other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ

PRIOR CONCURRENT THERAPY:

Chemotherapy:

• At least 3 weeks since prior chemotherapy

• No more than 2 prior chemotherapy regimens

Endocrine therapy:

• Concurrent steroids allowed at stable dose

Radiotherapy:

• No prior radiotherapy to study lesions

Other:

• At least 3 weeks since prior systemic retinoid or carotenoid therapy

• No concurrent anticonvulsants