3-AP in Treating Patients With Previously Untreated Locally Recurrent or Metastatic Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00075660
Recruitment Status : Completed
First Posted : January 12, 2004
Last Update Posted : November 9, 2010
National Cancer Institute (NCI)
Information provided by:
Canadian Cancer Trials Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as 3-AP, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have locally recurrent or metastatic renal cell (kidney) carcinoma (cancer).

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: triapine Phase 2

Detailed Description:



  • Determine the efficacy of 3-AP (Triapine®), in terms of objective response rate, in patients with previously untreated locally recurrent or metastatic renal cell carcinoma.


  • Determine the adverse events and tolerability of this drug in these patients.
  • Determine the time to disease progression and overall survival of patients treated with this drug.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive 3-AP (Triapine®) IV over 2 hours on days 1-4 and 15-18. Treatment repeats every 28 days for up to 6 courses (for stable patients) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional course after documentation of CR. Patients who achieve a partial response (PR) receive 2 additional courses after documentation of stable PR.

Patients are followed every 4 weeks until relapse and then every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1 year.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma
Study Start Date : January 2004
Actual Study Completion Date : September 2008

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed renal cell carcinoma

    • Locally recurrent OR metastatic disease
    • Incurable by standard therapy
  • Clinically and/or radiologically measurable disease

    • At least 1 unidimensionally measurable lesion* at least 20 mm by x-ray, physical exam, or non-spiral CT scan OR at least 10 mm by spiral CT scan
    • If the sole site of measurable disease is in a previously irradiated field, there must be documented disease progression at that site NOTE: *Bone lesions are not considered measurable disease
  • No documented brain metastases



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No glucose-6-phosphate dehydrogenase (G6PD) deficiency* NOTE: *Screening for G6PD deficiency is required for patients of African, Asian, or Mediterranean descent


  • Bilirubin normal
  • AST or ALT no greater than 2.5 times upper limit of normal (ULN)


  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 50 mL/min


  • No myocardial infarction within the past 6 months
  • No symptomatic congestive heart failure
  • No unstable angina
  • No active cardiomyopathy
  • No cardiac arrhythmia
  • No uncontrolled hypertension


  • No pulmonary disease requiring oxygen


  • HIV negative
  • No known hypersensitivity to compounds of similar chemical or biological composition to 3-AP (Triapine®)
  • No active uncontrolled or serious infection
  • No immunodeficiency


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor with no evidence of disease for at least 5 years
  • No history of significant neurologic or psychiatric disorder (e.g., uncontrolled psychotic disorders) that would preclude giving informed consent or complying with study requirements
  • No active peptic ulcer disease
  • No other serious illness or medical condition that would preclude study participation


Biologic therapy

  • More than 3 months since prior interferon for advanced or recurrent disease
  • No other prior immunotherapy for advanced or recurrent disease
  • No prior gene therapy


  • No prior systemic chemotherapy for advanced or recurrent disease

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy (except low-dose nonmyelosuppressive radiotherapy) and recovered


  • At least 2 weeks since prior major surgery


  • No prior investigational anticancer agents
  • No other concurrent anticancer agents or therapy
  • No other concurrent investigational therapy
  • No concurrent anticoagulants

    • Concurrent nontherapeutic warfarin or heparin allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00075660

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1
Sponsors and Collaborators
NCIC Clinical Trials Group
National Cancer Institute (NCI)
Study Chair: Jennifer Knox, MD Toronto General Hospital

Publications of Results: Identifier: NCT00075660     History of Changes
Other Study ID Numbers: I161
CDR0000347409 ( Other Identifier: PDQ )
First Posted: January 12, 2004    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: March 2010

Keywords provided by Canadian Cancer Trials Group:
recurrent renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases