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Sponsors and Collaborators: |
National Cancer Institute of Canada National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075660 |
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 |
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 |
Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell carcinoma
Clinically and/or radiologically measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent anticoagulants
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 |
Study Chair: | Jennifer Knox, MD | Toronto General Hospital |
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 |
recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer |
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 |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |