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3-AP in Treating Patients With Previously Untreated Locally Recurrent or Metastatic Renal Cell Carcinoma
This study has been completed.
Sponsors and Collaborators: National Cancer Institute of Canada
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075660
  Purpose

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 Intervention Phase
Kidney Cancer
Drug: triapine
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: 3-Aminopyridine-2-carboxaldehyde thiosemicarbazone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma

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

Study Start Date: January 2004
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  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 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • 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

Hepatic

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

Renal

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

Cardiovascular

  • 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

Pulmonary

  • No pulmonary disease requiring oxygen

Immunologic

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy

  • No prior systemic chemotherapy for advanced or recurrent disease

Endocrine therapy

  • Not specified

Radiotherapy

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

Surgery

  • At least 2 weeks since prior major surgery

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075660

Locations
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
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1
Sponsors and Collaborators
National Cancer Institute of Canada
Investigators
Study Chair: Jennifer Knox, MD Toronto General Hospital
  More Information

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

Publications of Results:
Study ID Numbers: CDR0000347409, CAN-NCIC-IND161, NCI-NCIC-161
Study First Received: January 9, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00075660  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 13, 2009