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. PURPOSE: Phase I trial to study the effectiveness of AG2037 in treating patients who have advanced, metastatic, or recurrent solid tumors.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose and dose-limiting toxic effects of AG2037 in patients with advanced, metastatic, or recurrent solid tumor. * Determine the safety and tolerance of this drug in these patients. * Assess the pharmacokinetics of this drug in these patients. * Document any antitumor effects of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive AG2037 IV weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of AG2037 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed weekly for 4 weeks. PROJECTED ACCRUAL: A total of 18-60 patients will be accrued for this study.
Interventions
DRUGpelitrexol
Sponsors
National Cancer Institute (NCI)
University of Alabama at Birmingham
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor * Advanced, metastatic, or recurrent disease * No curative therapy exists * Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute granulocyte 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 mg/dL (unless due to Gilbert's syndrome) * SGOT OR SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min Other: * No unstable or severe concurrent medical condition that would preclude study participation * No sociological or familial condition that would preclude study compliance * No psychological or addictive disorder that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * No prior radiotherapy to more than 40% of bone marrow Surgery: * Not specified Other: * At least 2 weeks since prior blood transfusions * At least 4 weeks since prior investigational agent and recovered * No prior glycinamide ribonucleotide formyltransferase (GARFT) inhibitor * No concurrent extradietary folate supplements * No concurrent allopurinol * No other concurrent anticancer or investigational agents
Countries
United States
Outcome results
None listed