Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Suramin in Treating Patients With Recurrent Bladder Cancer

Summary: 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.

Detailed description: 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: 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

Relevance to patient case: not relevant