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A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

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Trial Information

A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Adrian L. Harris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oxford Radcliffe Hospital

Authority:

United States: Federal Government

Study ID:

CRC-PHASE I/II-PH1/073

NCT ID:

NCT00006476

Start Date:

October 2000

Completion Date:

October 2007

Related Keywords:

  • Bladder Cancer
  • stage 0 bladder cancer
  • stage I bladder cancer
  • recurrent bladder cancer
  • Urinary Bladder Neoplasms

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