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

Kidney Cancer Clinical Trial

Official title:

A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075660
• Other study ID #: I161
• Secondary ID: CAN-NCIC-IND161C
• Status: Completed
• Phase: Phase 2
• Start date: May 11, 2004
• Est. completion date: September 22, 2008

Study information

• Verified date: April 2020
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 22, 2008
• Est. primary completion date: October 4, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• triapine

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 Dru — View Citation