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

NCT00075660 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: I161CAN-NCIC-IND161CDR0000347409
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 8

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).

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer; stage III renal cell cancer; stage IV renal cell cancer

Interventions

triapine DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L-4M1, Canada

Location

Related 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 Drugs. 2007 Oct;25(5):471-7. doi: 10.1007/s10637-007-9044-9. Epub 2007 Mar 28.

  PMID: 17393073 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Jennifer Knox, MD

  Toronto General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2004
• First Posted: January 12, 2004
• Study Start: May 11, 2004
• Primary Completion: October 4, 2005
• Study Completion: September 22, 2008
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)