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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
triapine
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cross Cancer Institute
  • British Columbia Cancer Agency
  • CancerCare Manitoba
  • Margaret and Charles Juravinski Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Toronto Sunnybrook Regional Cancer Centre
  • Toronto General Hospital
  • Centre Hospitalier de l'Universite de Montreal

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 9, 2004
Last Updated
August 3, 2023
Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00075660
Brief Title
3-AP in Treating Patients With Previously Untreated Locally Recurrent or Metastatic Renal Cell Carcinoma
Official Title
A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 11, 2004 (Actual)
Primary Completion Date
October 4, 2005 (Actual)
Study Completion Date
September 22, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
triapine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Knox, MD
Organizational Affiliation
Toronto General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L-4M1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17393073
Citation
Knox JJ, Hotte SJ, Kollmannsberger C, Winquist E, Fisher B, Eisenhauer EA. Phase II study of Triapine in patients with metastatic renal cell carcinoma: a trial of the National Cancer Institute of Canada Clinical Trials Group (NCIC IND.161). Invest New Drugs. 2007 Oct;25(5):471-7. doi: 10.1007/s10637-007-9044-9. Epub 2007 Mar 28.
Results Reference
result

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

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