Phase I/II Trial Of Low Dose Suramin (CI-1003, NSC#34936) And 5-Fluorouracil In Patients With Metastatic Renal Cell Carcinoma (RCC)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

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Trial Information

Phase I/II Trial Of Low Dose Suramin (CI-1003, NSC#34936) And 5-Fluorouracil In Patients With Metastatic Renal Cell Carcinoma (RCC)


PRIMARY OBJECTIVES:

I. Determine the dose of suramin and fluorouracil that would result in plasma concentrations
of suramin between 10-50 uM in patients with metastatic renal cell cancer. (Phase I) II.
Determine the objective response rate (complete response and partial response) in patients
treated with this regimen. (Phase II)

SECONDARY OBJECTIVES:

I. Determine the preliminary efficacy of this regimen in these patients. (Phase I) II.
Determine the pharmacokinetics of low-dose suramin in these patients. (Phase I) III.
Determine the time to tumor progression and progress rate at 3 and 6 months in patients
treated with this regimen. (Phase II)

OUTLINE: This is a dose-escalation phase I study followed by a phase II study.

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.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose of suramin to deliver the target plasma concentrations of 10 to 50 uM (Phase I)

Outcome Time Frame:

Up to 48 hours

Safety Issue:

No

Principal Investigator

Ronald Bukowski

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02586

NCT ID:

NCT00083109

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Recurrent Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma, Renal Cell

Name

Location
Cleveland Clinic Foundation Cleveland, Ohio  44195