Suramin in Treating Patients With Recurrent Bladder Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006476
First received: November 6, 2000
Last updated: June 25, 2013
Last verified: March 2007

November 6, 2000
June 25, 2013
October 2000
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00006476 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Suramin in Treating Patients With Recurrent Bladder Cancer
A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
Bladder Cancer
  • Drug: suramin
  • Procedure: conventional surgery
Not Provided
Ord JJ, Streeter E, Jones A, Le Monnier K, Cranston D, Crew J, Joel SP, Rogers MA, Banks RE, Roberts IS, Harris AL. Phase I trial of intravesical Suramin in recurrent superficial transitional cell bladder carcinoma. Br J Cancer. 2005 Jun 20;92(12):2140-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
October 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00006476
CRC-PHASE I/II-PH1/073, CDR0000068303, NCI-954
Not Provided
Not Provided
Cancer Research UK
Not Provided
Study Chair: Adrian L. Harris, MD Oxford University Hospitals NHS Trust
National Cancer Institute (NCI)
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP