This trial is active, not recruiting.

Condition unspecified adult solid tumor, protocol specific
Treatment talotrexin ammonium
Phase phase 1
Sponsor Dana-Farber Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date October 2004
Trial size 40 participants
Trial identifier NCT00098514, CDR0000400150, DFCI-02000, DFCI-IRB-03183, HANABIO-DFCI-02000, NCI-6400


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase I Study Of PT523 In Patients With Solid Tumors
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).