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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00024245 |
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 | Intervention | Phase |
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: 10-propargyl-10-deazaaminopterin Drug: probenecid |
Phase I |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | 10-Propargyl-10-deazaaminopterin Probenecid |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I and Clinical Pharamcologic Study of 10-Propargyl-10-Deazaaminopterin (PDX) in Combination With Probenecid in Adults With Advanced Solid Tumors |
Study Start Date: | May 2001 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cancer that is potentially incurable by standard chemotherapy, radiotherapy, or surgical procedures
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | |||||
New York, New York, United States, 10021 |
Memorial Sloan-Kettering Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Naiyer Rizvi, MD | Memorial Sloan-Kettering Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068905, MSKCC-01014, NCI-H01-0077 |
First Received: | September 13, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00024245 |
Health Authority: | United States: Federal Government |
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