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3-AP and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2007
First Received: February 16, 2006   Last Updated: February 2, 2010   History of Changes
Sponsor: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00293345
  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.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: gemcitabine hydrochloride
Drug: triapine
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: June 2006
Estimated Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293345

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service     866-627-7616     osu@emergingmed.com    
Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Investigators
Principal Investigator: Tanios Bekaii-Saab, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000455043, OSU-05016, OSU-2005C0031, NCI-7043
Study First Received: February 16, 2006
Last Updated: February 2, 2010
ClinicalTrials.gov Identifier: NCT00293345     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
intraocular lymphoma
nodal marginal zone B-cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
small intestine lymphoma
splenic marginal zone lymphoma
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult T-cell leukemia/lymphoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Ileal Diseases
Duodenal Neoplasms
Neoplasms by Site
Ileal Neoplasms
Jejunal Diseases
Therapeutic Uses
Lymphoma, Large-Cell, Immunoblastic
Gemcitabine
Lymphoma
Duodenal Diseases
Jejunal Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Digestive System Neoplasms
Immune System Diseases
Enzyme Inhibitors
Intestinal Diseases
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Intestinal Neoplasms
Lymphatic Diseases

ClinicalTrials.gov processed this record on February 08, 2010