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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00075660
First received: January 9, 2004
Last updated: November 7, 2010
Last verified: March 2010
  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 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Study Start Date: January 2004
Study Completion Date: September 2008
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
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
NCIC Clinical Trials Group
Investigators
Study Chair: Jennifer Knox, MD Toronto General Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00075660     History of Changes
Other Study ID Numbers: I161, CAN-NCIC-IND161, NCI-NCIC-161, CDR0000347409
Study First Received: January 9, 2004
Last Updated: November 7, 2010
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical 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
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014