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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00024245
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
Sponsor:
Collaborator:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: pralatrexate Drug: probenecid Phase 1

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: 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
Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00024245


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Naiyer Rizvi, MD Memorial Sloan Kettering Cancer Center
More Information

ClinicalTrials.gov Identifier: NCT00024245     History of Changes
Other Study ID Numbers: MSKCC-01014
CDR0000068905 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-H01-0077
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: March 2003

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Probenecid
10-deazaaminopterin
Aminopterin
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents
Antineoplastic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action