Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer
About this trial
This is an interventional treatment trial for Recurrent Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed renal cell cancer Metastatic disease Measurable or evaluable disease Measurable disease required for phase II No untreated CNS metastasis or CNS metastases progressing ≤ 4 weeks after prior radiotherapy Performance status - ECOG 0-1 At least 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9.0 g/dL AST ≤ 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 5 times ULN Bilirubin ≤ 1.5 mg/dL Creatinine ≤ 1.8 mg/dL Calcium ≤ ULN No untreated hypercalcemia No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must be surgically sterile or use effective contraception No uncontrolled diabetes mellitus No known severe hypersensitivity to suramin No other concurrent uncontrolled illness No active or ongoing infection No active autoimmune disease No neuropathy ≥ grade 2 No psychiatric illness or social situation that would preclude study compliance No other malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or localized prostate cancer No concurrent filgrastim (G-CSF) No more than 2 prior chemotherapy regimens for renal cell cancer (phase II only) No concurrent corticosteroid dose more than physiologic replacement levels See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy Recovered from prior oncologic or other major surgery At least 4 weeks since prior major surgery No concurrent surgery Recovered from all prior anticancer therapy other than alopecia (chronic toxicity < grade 2) At least 4 weeks since prior systemic therapy More than 30 days since prior investigational drugs Concurrent bisphosphonates allowed
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Experimental
Treatment (suramin and fluorouracil)
PHASE I: Patients receive suramin IV over 30 minutes and fluorouracil IV on days 1, 8, 15, 22, 29, and 36. Cohorts of 3-6 patients receive escalating doses suramin and fluorouracil until the dose level allowing 10-50 uM of suramin into the patient's blood is determined without 2 or more of 6 patients experiencing dose-limiting toxicity. PHASE II: Patients receive suramin and fluorouracil (at the dose level determined in phase I) as in phase I. In both phases, courses repeat every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.