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

NCT00024245 | Completed Phase 1

• 3 other identifiers: MSKCC-01014CDR0000068905NCI-H01-0077
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

pralatrexate DRUG

probenecid DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

10-propargyl-10-deazaaminopterin; Probenecid

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Naiyer Rizvi, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: May 1, 2001
• Study Completion: April 1, 2003
• Last Updated: June 26, 2013

Record last verified: 2003-03

Locations

US (1)