Clinical trial · Interventional
Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
Phase I/II Trial Of Low Dose Suramin (CI-1003, NSC#34936) And 5-Fluorouracil In Patients With Metastatic Renal Cell Carcinoma (RCC)
NCT00083109CI-TRIAL-00018019completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug. This phase I/II trial is studying the side effects and best dose of fluorouracil and the chemosensitizer suramin and to see how well they work in treating patients with metastatic renal cell (kidney) cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IV Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Pharmacological Study | Other | — | UNRESOLVED |
| Suramin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (suramin and fluorouracil)
- description
- 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.
- interventionNames
- Drug: Fluorouracil
- Other: Pharmacological Study
- Drug: Suramin
Primary outcomes (2)
- measure
- Dose of suramin to deliver the target plasma concentrations of 10 to 50 uM (Phase I)
- timeFrame
- Up to 48 hours
- measure
- Objective response rate (CR + PR) using RECIST criteria (Phase II)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.