Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma

NCT00003346 | Completed Phase 2

• 3 other identifiers: 97-124CDR0000066323NCI-H98-0014
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Interventions

acetaminophen DRUG

acetylcysteine DRUG

carmustine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Acetaminophen; Acetylcysteine; Carmustine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nitrosourea Compounds; Urea; Nitroso Compounds

Study Officials

• Paul B. Chapman, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 25, 2003
• Study Start: November 1, 1997
• Primary Completion: February 1, 2003
• Study Completion: February 1, 2003
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

US (1)