Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying side effects, best way to give, and best dose of talotrexin in treating patients with advanced or recurrent solid tumors.
Detailed description
OBJECTIVES: Primary * Determine the maximum tolerated dose of talotrexin in patients in patients with advanced or recurrent solid tumors. * Determine the safety of this drug in these patients. * Determine the dose-limiting toxic effects of this drug in these patients. Secondary * Determine the pharmacokinetics of this drug in these patients. * Correlate pharmacokinetic parameters of this drug or patient characteristics with drug-related toxicity in these patients. * Determine, preliminarily, the antitumor efficacy of this drug in these patients. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive talotrexin IV over 5 minutes on day 1 OR days 1 and 8 OR days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of talotrexin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6-10 patients are treated at the MTD. Patients are followed at 1 month. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 9-12 months.
Interventions
DRUGtalotrexin ammonium
Sponsors
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
There were 7 potential PT523 single agent dose levels to be evaluated in this phase I study
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of malignant solid tumor * Metastatic or inoperable disease * No known curative or survival-prolonging palliative therapy exists OR failed these prior therapies * No leukemia * No primary CNS tumor * No third-space fluid collection (i.e., pleural effusion, ascites) * Clinically insignificant small pleural or peritoneal effusions identified by CT scan, MRI, or other diagnostic test allowed * No active\* brain metastases, including the following: * Evidence of cerebral edema by CT scan or MRI * Progression since prior imaging study * Requirement for steroids * Clinical symptoms of/from brain metastases NOTE: \*Treated and/or stable brain metastasis allowed provided patient is asymptomatic PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 2 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * RBC folate ≥ lower limit of normal Hepatic * Bilirubin normal * SGOT and SGPT ≤ 2.5 times upper limit of normal Renal * Creatinine clearance ≥ 50 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other uncontrolled serious medical or psychiatric illness PRIOR CONCURRENT THERAPY: Biologic therapy * No prior bone marrow transplantation Chemotherapy * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy * See Disease Characteristics Radiotherapy * More than 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * At least 3 weeks since prior surgery Other * Recovered from prior therapy * More than 3 weeks since prior antifolate therapy
Countries
United States
Outcome results
None listed