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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: triapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: triapine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer