3-AP and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma
Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
About this trial
This is an interventional treatment trial for Anaplastic Large Cell Lymphoma
Eligibility 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
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (gemcitabine hydrochloride, triapine)
Patients receive 3-AP (Triapineî) 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.