Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Drugs used in chemotherapy such as polyglutamate camptothecin may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged. PURPOSE: Phase I trial to study the effectiveness of polyglutamate camptothecin in treating patients who have advanced cancer.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of polyglutamate camptothecin (CT-2106) in patients with advanced malignancies. * Determine the tolerability of this drug in these patients. * Determine the safety of this drug in these patients. * Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. * Determine the disease response in patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. Patients receive polyglutamate camptothecin (CT-2106) IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond confirmation of complete response. Cohorts of 3-6 patients receive escalating doses of CT-2106 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. Patients are followed at 3 weeks. PROJECTED ACCRUAL: A total of 12-48 patients will be accrued for this study.
Interventions
DRUGpolyglutamate camptothecin
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed advanced malignancy * No active brain metastases (as indicated by clinical symptoms, cerebral edema, or progressive tumor growth) that have been unstable for at least 8 weeks PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) Renal * Creatinine no greater than 1.5 times ULN * No history of hemorrhagic cystitis * No history of microscopic hematuria associated with drug therapy or radiotherapy or of unknown origin Cardiovascular * No significant cardiac disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to comply with study schedule and assessments * No other significant nonmalignant systemic disease * No active infection * No other condition that would in the investigator's opinion make the patient an inappropriate study candidate PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No more than 3 prior chemotherapy regimens * More than 4 weeks since prior chemotherapy Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior definitive radiotherapy (except for palliative reasons to sites of nonmeasurable disease, in patients with measurable disease at baseline) * Concurrent palliative radiotherapy allowed Surgery * More than 4 weeks since prior major thoracic or abdominal surgery Other * Recovered from prior therapy (except alopecia or stable grade 1 neuropathy) * More than 4 weeks since prior investigational agents * No prior myeloablative therapy
Countries
United States
Outcome results
None listed