Clinical trial NCT00075660 (phase 2, status: completed)
Conditions: kidney cancer
ICD codes: D17.71, D30.00, D30.01, D30.02, D41.00, D41.01, D41.02
Drugs: triapine
SMILES: NC(=S)N\N=C\C1=C(N)C=CC=N1
Eligibility 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