Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: I. Determine the efficacy of fenretinide, in terms of complete and partial response rates, duration of response, and survival, in patients with recurrent small cell lung cancer. II. Determine the toxicity of this regimen in these patients. III. Correlate the induction of apoptosis or the expression of molecular mediators of apoptosis in tumor cells with response rates, response duration, and survival in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive oral fenretinide twice daily on days 1-7. Treatment continues every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month.

Official Title
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Phase II Trial Of Fenretinide (NSC-374551; IND-40, 294) In Patients With Relapsed Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: fenretinide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive oral fenretinide twice daily on days 1-7. Treatment continues every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. | Drug: fenretinide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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limited stage small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer