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3-AP in Treating Patients With Advanced or Metastatic Solid Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: California Cancer Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00390052
  Purpose

RATIONALE: 3-AP may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of 3-AP in treating patients with advanced or metastatic solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: triapine
Procedure: pharmacological study
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: 3-Aminopyridine-2-carboxaldehyde thiosemicarbazone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Title: A Phase 1 and Pharmacokinetic Study of Oral 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine®) in the Treatment of Advanced Solid Tumors

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

Primary Outcome Measures:
  • Maximum tolerated dose of oral 3-AP [ Designated as safety issue: Yes ]
  • Toxicity as measured by NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2006
Estimated Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the safety, tolerability, and toxicity of oral 3-AP in patients with advanced solid tumors.
  • Determine the maximum tolerated dose and recommended phase II dose of this drug in these patients.
  • Determine the oral bioavailability and pharmacokinetics of this drug.
  • Assess tumoral expression of genes involved in response and resistance to 3-AP.
  • Observe and record any tumor response in these patients.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive a one time dose of 3-AP IV over 2 hours on day -7. Patients then receive oral 3-AP twice daily on days 1-3, 8-10, and 15-17. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of oral 3-AP 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.

Blood samples for pharmacokinetic analysis are collected periodically over 8 hours after the IV dose of 3-AP and after the first oral dose of 3-AP during course 1.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 24 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 confirmed solid tumor

    • Advanced or metastatic disease
  • Progressive disease during ≥ 1 prior standard therapy OR disease unlikely to respond to any currently available therapies
  • Measurable or evaluable disease
  • No known active CNS metastases

    • Patients with previously treated CNS metastases who have no evidence of new CNS metastases AND are stable for ≥ 2 months are eligible

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy > 3 months
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL (transfusions allowed)
  • Absolute neutrophil count ≥ 1,500/mm^3
  • ALT and AST ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
  • Bilirubin normal
  • PT/PTT ≤ 1.5 times ULN
  • FEV_1 ≥ 1.2 L
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception 2 weeks prior to and during study treatment
  • Must be able to swallow
  • No mental deficits and/or psychiatric history that may preclude study treatment
  • No active heart disease, including any of the following:

    • Myocardial infarction within the past 3 months
    • Symptomatic coronary artery disease or heart block
    • Uncontrolled congestive heart failure
  • No moderate to severe compromise of pulmonary function
  • No active infection
  • No other life-threatening illness
  • No active coagulation disorder other than occult blood
  • No known positivity for glucose-6-phosphate dehydrogenase (G6PD) deficiency

PRIOR CONCURRENT THERAPY:

  • Recovered from prior treatment
  • Prior gemcitabine allowed
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • More than 3 weeks since prior radiotherapy or any other treatment for this cancer
  • No prior 3-AP
  • No concurrent radiotherapy
  • No other concurrent investigational agent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390052

Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen     800-826-4673     becomingapatient@coh.org    
City of Hope Medical Group Recruiting
Pasadena, California, United States, 91105
Contact: Mark V. McNamara, MD     626-396-2900     mmcnamara@ccsmg.com    
Contra Costa Regional Medical Center Recruiting
Martinez, California, United States, 94553
Contact: David R. Gandara, MD     925-372-2064        
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer     916-734-3089        
USC/Norris Comprehensive Cancer Center and Hospital Recruiting
Los Angeles, California, United States, 90089-9181
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente     323-865-0451        
United States, Pennsylvania
UPMC Cancer Centers Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Clinical Trials Office - UPMC Cancer Centers     412-647-8073        
Sponsors and Collaborators
California Cancer Consortium
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000507731, CCC-PHI-52, CHNMC-PHI-52
Study First Received: October 18, 2006
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00390052  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on January 15, 2009