Status:
COMPLETED
3-AP and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 chemothera...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximal tolerable dose (MTD) of 3-AP administered as a 24 hour infusion in combination with and fixed-dose gemcitabine hydrochloride (GEM) in patients with adv...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00293345
Start Date
June 1 2006
Last Update
September 30 2013
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210