Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Boston, Massachusetts 02115


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.

Study summary:

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.


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



Primary Contact:

Principal Investigator
Joseph Paul Eder, MD

Backup Contact:


Location Contact:

Boston, Massachusetts 02115
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.