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3-AP and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma - NCT00293345-43210(Clinical Trial 137816)



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City:  Columbus
State:  
OH
Zip Code: 43210
Conditions: Brain and Central Nervous System Tumors - Lymphoma - Small Intestine Cancer - Unspecified Adult Solid Tumor, Protocol Specific
Purpose: 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.
Study summary: 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.
Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed advanced solid tumors or lymphoma - Disease considered incurable using standard treatment PATIENT CHARACTERISTICS: - ECOG performance status ≤ 2 - Life expectancy > 12 weeks - WBC ≥ 3,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Total bilirubin normal - AST/ALT ≤ 2.5 times upper limit of normal - Creatinine normal OR creatinine clearance ≥ 60 mL/min - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception prior to and during study treatment - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to 3-AP (Triapine®) and/or gemcitabine hydrochloride - No known glucose-6-phosphate dehydrogenase (G6PD) deficiency - No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements - No pulmonary disease (e.g., dyspnea at rest, supplemental oxygen requirement, or baseline oxygen saturation < 92%) PRIOR CONCURRENT THERAPY: - Prior gemcitabine hydrochloride allowed if given as a standard 30-minute infusion - At least 4 weeks since prior gemcitabine hydrochloride - Patient may have received < 2 lines of chemotherapy in the metastatic setting - No prior 3-AP (Triapine®) or fixed-dose gemcitabine hydrochloride - At least 6 weeks since prior nitrosoureas or mitomycin C - More than 3 weeks since prior radiotherapy - No other concurrent investigational agents - No concurrent combination antiretroviral therapy in HIV-positive patients - No other concurrent anticancer agents or therapies
Study is available at: Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, OH 43210
United States

Primary Contact:
Ohio State University Cancer Clinical Trial Matching Service
Email: osu@emergingmed.com
Phone: 866-627-7616
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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