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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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. Drugs used in chemotherapy, such as 3-AP and gemcitabine (GEM), 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed advanced solid tumors or lymphoma

• Disease considered incurable using standard treatment

• 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 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