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3-AP and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma

2014-08-27 03:46:04 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 3-AP may help gemcitabine kill more cancer cells by making the cells more sensitive to the drug. 3-AP may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the best dose of 3-AP and the side effects of giving 3-AP together with gemcitabine in treating patients with advanced solid tumors or lymphoma.

Description

OBJECTIVES:

Primary

- Determine the maximum tolerated dose of 3-AP (Triapine®) and fixed-dose gemcitabine hydrochloride in patients with advanced solid tumors or lymphomas.

- Define the qualitative and quantitative toxicities of this regimen in regard to organ specificity, time course, predictability, and reversibility.

- Document the therapeutic response of this regimen.

- Measure deoxycytidine triphosphate levels in peripheral blood mononuclear cells before and after treatment at specified times and correlate findings to activity and toxicity of 3-AP (Triapine®).

- Perform limited pharmacokinetic analysis.

OUTLINE: This is a dose-escalation study of 3-AP (Triapine®).

Patients receive 3-AP (Triapine®) IV over 24 hours followed by gemcitabine hydrochloride IV over 100-125 minutes on days 1 and 8. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 1 additional course of therapy beyond documented CR.

Cohorts of 3-6 patients receive escalating doses of 3-AP (Triapine®) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Brain and Central Nervous System Tumors

Intervention

gemcitabine hydrochloride, triapine

Location

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus
Ohio
United States
43210-1240

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:46:04-0400

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Neoplasms of the intracranial components of the central nervous system, including the cerebral hemispheres, basal ganglia, hypothalamus, thalamus, brain stem, and cerebellum. Brain neoplasms are subdivided into primary (originating from brain tissue) and secondary (i.e., metastatic) forms. Primary neoplasms are subdivided into benign and malignant forms. In general, brain tumors may also be classified by age of onset, histologic type, or presenting location in the brain.

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