Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
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 trial to study the effectiveness of combining 3-AP with cisplatin in treating patients who have advanced cancer.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of cisplatin when administered with 3-AP in patients with advanced cancer. * Determine the toxic effects of this regimen in these patients. * Determine the antitumor responses in patients treated with this regimen. OUTLINE: This is a dose-escalation study of cisplatin. Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed progressive malignant disease that has failed at least 1 conventional treatment or is unlikely to respond to current therapy * Measurable or evaluable disease * Elevated serum tumor marker considered evaluable disease * No known active CNS metastases * Previously treated CNS metastases with no evidence of new CNS metastases allowed if stable for at least 2 months PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL (transfusion allowed) * No active bleeding or coagulation disorder (except occult blood related to gastrointestinal cancer) Hepatic: * Bilirubin no greater than 2.0 mg/dL * ALT and AST no greater than 3 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 5 times ULN * PT and PTT no greater than 1.5 times ULN Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No active heart disease * No myocardial infarction within the past 3 months * No symptomatic coronary artery disease * No uncontrolled arrhythmias * No uncontrolled congestive heart failure Pulmonary: * No moderate to severe compromise of pulmonary function Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infectious process * No pre-existing severe hearing impairment * No grade 2 or greater neuropathy * No other life threatening illness * No prior severe allergic reaction to cisplatin * No mental deficits and/or psychiatric history that would preclude study * No persistent chronic toxic effects from prior chemotherapy greater than grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 2 weeks since prior biologic therapy Chemotherapy: * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * At least 3 months since prior cisplatin or platinum analogue * No prior 3-AP Endocrine therapy: * At least 2 weeks since prior hormonal therapy Radiotherapy: * More than 3 weeks since prior radiotherapy Surgery: * At least 3 weeks since prior major surgery and recovered Other: * No other concurrent investigational drugs * No other concurrent nephrotoxic drugs (e.g., aminoglycoside antibiotics)
Countries
United States