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Phase II Study of Intravesical Therapy With AD 32 in Patients With Papillary Urothelial Carcinoma or Carcinoma in Situ (CIS) Refractory to Prior Therapy With Bacillus Calmette-Guerin

Phase 2
18 Years
Not Enrolling
Bladder Cancer

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Trial Information

Phase II Study of Intravesical Therapy With AD 32 in Patients With Papillary Urothelial Carcinoma or Carcinoma in Situ (CIS) Refractory to Prior Therapy With Bacillus Calmette-Guerin


- Determine the recurrence rate and disease free survival in patients with recurrent or
refractory papillary transitional cell carcinoma of the bladder with or without
carcinoma in situ of the bladder treated with intravesical AD 32.

- Evaluate the safety of administering this drug in these patients.

- Determine the effectiveness of this drug, in terms of recurrence rates and disease free
survival, in these patients.

OUTLINE: Patients are stratified according to cellular diagnosis (papillary transitional
cell carcinoma (Ta/T1) with no carcinoma in situ (Tis) vs Tis with or without Ta/T1).

Patients receive intravesical AD 32 once a week for 6 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed recurrent superficial bladder cancer defined as papillary
transitional cell carcinoma (stage Ta/T1) and/or carcinoma in situ (stage Tis) of the
urinary bladder

- No evidence of invasion of the underlying muscle (stage T2) at baseline

- Must meet 1 of the following criteria:

- Failure of at least 2 prior courses of intravesical therapy, 1 of which must
have been a course of BCG

- Recurrent or persistent disease within 6 months after failing a 6-week course of
BCG followed by maintenance therapy

- Inability or ineligibility to complete 1 course of intravesical therapy with
BCG, and failure of 2 prior courses of intravesical therapy with an alternative

- Diagnosis must have been made no more than 24 months after completion of prior
treatment with intravesical immunotherapy or chemotherapy

- If carcinoma in situ is current or previous diagnosis, the biopsies must be obtained
from at least 4 sites (bladder mapping)

- If prostatic urothelial biopsy discloses carcinoma in situ, transurethral prostatic
resection must be carried out prior to study

- Papillary disease must have undergone complete transurethral resection (TURBT) within
28 days before study



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified


- WBC greater than 4,000/mm^3

- Platelet count greater than 100,000/mm^3


- Bilirubin less than 2 times upper limit of normal (ULN)

- SGOT and SGPT less than 3 times ULN


- Creatinine no greater than 2.5 mg/dL


- Normal upper tract (ureter and renal pelvic) evaluation within 6 months

- No known sensitivity to anthracyclines or to Cremophor EL

- HIV negative

- No known AIDS or HIV-1 associated complex

- No other significant concurrent illness

- No other prior malignancy within the past 3 years except superficial bladder cancer,
adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of
the cervix

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- See Disease Characteristics

- No concurrent biological response modifier therapy


- See Disease Characteristics

- Prior oral bropirimine for bladder cancer allowed

- No prior AD 32 for bladder cancer

- No other intravenously administered systemic chemotherapy for bladder cancer

- No concurrent chemotherapy for any other malignancy

Endocrine therapy:

- No concurrent hormonal therapy


- No prior radiotherapy

- No concurrent radiotherapy


- See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Jeffrey M. Ignatoff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NorthShore University HealthSystem Research Institute


United States: Federal Government

Study ID:




Start Date:

July 1998

Completion Date:

Related Keywords:

  • Bladder Cancer
  • stage 0 bladder cancer
  • stage I bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms
  • Carcinoma



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