10-Propargyl-10-Deazaaminopterin Plus Probenecid in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: 10-deazaaminopterin; Aminopterin; Probenecid

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