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

• Status: Completed
• Trial end date: 2008-09-22
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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