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

This study has been completed.

Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)

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.

Condition Treatment or Intervention Phase
unspecified adult solid tumor, protocol specific
 Drug: 10-propargyl-10-deazaaminopterin
 Drug: probenecid
 Procedure: chemotherapy
 Procedure: drug modulation
Phase I

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of 10-Propargyl-10-Deazaaminopterin and Probenecid in Patients With Advanced Solid Tumors

Further Study Details: 

OBJECTIVES:

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

Performance status:

Life expectancy:

Hematopoietic:

Hepatic:

Renal:

Cardiovascular:

Other:

PRIOR CONCURRENT THERAPY: Biologic therapy:

Chemotherapy:

Endocrine therapy:

Radiotherapy:

Surgery:

Other:


Location Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068905; MSKCC-01014; NCI-H01-0077
Record last reviewed:  April 2003
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00024245
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29
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