Clinical trial · Interventional
Fenretinide in Treating Patients With Solid Tumors
Phase I Evaluation of Fenretinide (NSC# 374551)
NCT00003250CI-TRIAL-00014237completedPhase 1ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of fenretinide in treating patients who have solid tumors.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fenretinide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the maximum tolerated dose (MTD) and toxicities of 4-HPR
- timeFrame
- per cycle
- description
- When drug is administered orally three times daily for 21 doses, repeated every 21 days.
Secondary outcomes (1)
- measure
- Characterize the pharmacokinetics of 4-HPR and its metabolite(s)
- timeFrame
- Pre-treatment; Cycle 1 Days 1 & 8: 1, 2, 4, 6, 8, 12, 24 hrs & day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.