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

NCIC Clinical Trials Group

Status and phase

Completed

Phase 2

Conditions

Kidney Cancer

Treatments

Drug: triapine

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00075660

CDR0000347409 (Other Identifier)

I161

CAN-NCIC-IND161 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

19 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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