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Phase I and Clinical Pharamcologic Study of 10-Propargyl-10-Deazaaminopterin (PDX) in Combination With Probenecid in Adults With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I and Clinical Pharamcologic Study of 10-Propargyl-10-Deazaaminopterin (PDX) in Combination With Probenecid in Adults With Advanced Solid Tumors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Naiyer Rizvi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

MSKCC-01014

NCT ID:

NCT00024245

Start Date:

May 2001

Completion Date:

April 2003

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021