Clinical trial · Interventional
Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
Phase II Trial Of Fenretinide (NSC-374551; IND-40, 294) In Patients With Relapsed Small Cell Lung Cancer
NCT00009971CI-TRIAL-00009411completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fenretinide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Drug: fenretinide
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.