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

Conditions:Colorectal Cancer, Cancer, Cancer, Brain Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Infectious Disease, Lymphoma, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology
Age Range:Any
Start Date:June 2006

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A Phase I Study of a Prolonged Infusion of Triapine in Combination With a Fixed Dose Rate of Gemcitabine in Patients With Advanced Solid Tumors and Lymphomas

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


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 advanced
solid tumors or lymphomas.


I. To define the qualitative and quantitative toxicities of the 3-AP/GEM combination in
regard to organ specificity, time course, predictability, and reversibility.

II. To document the therapeutic response of this combination in those patients when

III. To measure deoxycytidine triphosphate (dCTP) levels in peripheral blood mononuclear
cells (PBMCs) before and after treatment at specified times and try to correlate findings to
activity and toxicity of 3-AP.

IV. To 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.

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
We found this trial at
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
Columbus, OH
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