Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
Phase I-II Trial of High-Dose Acetaminophen With Carmustine in Patients With Metastatic Melanoma
NCT00003346CI-TRIAL-00011036completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of acetaminophen plus carmustine in treating patients who have stage III or stage IV melanoma.
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 |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acetaminophen | Drug | — | UNRESOLVED |
| acetylcysteine | Drug | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma or stage III melanoma not potentially curable by surgery * Phase I: (closed to accrual 3/7/2001) measurable or evaluable disease required * Phase II: At least 2 measurable subcutaneous or cutaneous metastases that are accessible for biopsy PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 4,000/mm\^3 * Hemoglobin at least 9 g/dL * Platelet count at least 100,000/mm\^3 * No active bleeding Hepatic: * AST less than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase less than 1.5 times ULN * PT/PTT within normal range Renal: * Not specified Pulmonary: * No interstitial lung disease or unexplained interstitial infiltrates on chest x-ray * No chronic obstructive pulmonary disease * No asthma requiring treatment Other: * No active infection requiring antimicrobial drugs * Not pregnant or nursing * Fertile patients must use effective barrier contraception * No allergies to acetaminophen or acetylcysteine PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin) * No prior nitrosoureas * No prior hepatic perfusions with chemotherapy Endocrine therapy: * No concurrent oral contraceptives Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * Not specified Other: * No concurrent vitamin, mineral, or garlic supplements * At least 7 days since prior garlic or alcohol * No concurrent treatment with medications known to affect P450 hepatic enzymes * No concurrent treatment with calcium channel blockers
References
Publications (0)
Data not yet available
No reference posted for this study.