Suramin in Treating Patients With Recurrent Bladder Cancer
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Purpose
RATIONALE: Suramin may stop the growth of bladder cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of suramin in treating patients who have recurrent bladder cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: suramin Procedure: conventional surgery |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer |
| Estimated Enrollment: | 15 |
| Study Start Date: | October 2000 |
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of suramin in patients with recurrent superficial bladder cancer.
- Confirm that there is no significant systemic absorption of this drug when administered intravesically in these patients.
OUTLINE: This is a dose escalation study.
At approximately 14-18 days after surgical resection of bladder tumor(s), patients receive intravesicular suramin via urethral catheter installation into the bladder over 2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of suramin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients develop dose-limiting toxicity.
Patients are followed at 2-4 weeks.
PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study over 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven recurrent superficial bladder cancer
Intermediate prognosis as defined by the following:
- Recurrent, multiple Ta, T1 carcinoma
- Multiple (1-7) tumors
- Tumors resected previously must be histological grade G1 or G2 OR
Previously treated superficial bladder cancer requiring followup cystoscopy
- Recurrent disease diagnosed at surgery
- No tumor invasion into muscle or carcinoma in situ
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,500/mm3
- Platelet count at least 150,000/mm3
Hepatic:
- No clinically significant hepatic disease
Renal:
- Creatinine clearance greater than 60 mL/min
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
- No history of adrenal insufficiency
- No other malignancy within the past 5 years except adequately treated cone-biopsied carcinoma in situ of the cervix or nonmelanoma skin cancer
- No history of difficult catheterization
- No confusion or disorientation
- No other condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy
Chemotherapy:
- No concurrent chemotherapy
Endocrine therapy:
- No concurrent corticosteroids
Radiotherapy:
- No prior radiotherapy to the bladder
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior major thoracic or abdominal surgery
Other:
- Recovered from prior therapy and stable for 4 weeks
- At least 6 weeks since prior intravesicular therapy
- No prior or concurrent investigational drugs
- No concurrent anticoagulants
Contacts and Locations
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00006476 History of Changes |
| Other Study ID Numbers: | CDR0000068303, CRC-PHASE I/II-PH1/073, NCI-954 |
| Study First Received: | November 6, 2000 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage 0 bladder cancer stage I bladder cancer recurrent bladder cancer |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Suramin Antinematodal Agents |
Anthelmintics Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Trypanocidal Agents Antiprotozoal Agents |
ClinicalTrials.gov processed this record on May 23, 2013