Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Probenecid may increase the effectiveness of 10-propargyl-10-deazaaminopterin by making tumor cells more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of combining 10-propargyl-10-deazaaminopterin and probenecid in treating patients who have advanced solid tumors.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of 10-propargyl-10-deazaaminopterin and probenecid in patients with advanced solid tumors. - Determine the therapeutic activity of this regimen in these patients. - Determine the toxic effects of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation study of 10-propargyl-10-deazaaminopterin (PDX) and probenecid. Patients receive probenecid IV and PDX IV on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive sequentially escalating doses of probenecid and PDX until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 35-40 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed cancer that is potentially incurable by standard chemotherapy, radiotherapy, or surgical procedures - Failed prior first-line therapy (patients are also eligible if no effective first-line therapy exists) - Previously treated or clinically stable brain metastases are allowed - No leukemia or lymphoma - No clinically significant pleural effusions or ascites PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 4,000/mm^3 - Platelet count at least 160,000/mm^3 - Hemoglobin greater than 10 g/dL - Serum and RBC folate normal Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT or SGPT less than 2 times upper limit of normal Renal: - Creatinine no greater than 1.2 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No unstable angina - No congestive heart failure - No cardiac arrhythmia Other: - Homocysteine normal - No grade III or IV edema - Not pregnant or nursing - Fertile patients must use effective contraception during and for 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy (4 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy to bone marrow-containing areas and recovered Surgery: - See Disease Characteristics - No prior pneumonectomy Other: - No concurrent folic acid or potentially nephrotoxic agents


NCT ID:

NCT00024245


Primary Contact:

Study Chair
Naiyer Rizvi, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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