A Randomized, Multicenter Phase III Trial Evaluating the Efficacy and Safety of BCI-ImmuneActivator Versus Adriamycin in BCG Refractory or Intolerant Patients With Carcinoma in Situ With or Without Resected Superficial Papillary Bladder Cancer
18 Years
N/A
Both
Bladder Cancer
Trial Information
A Randomized, Multicenter Phase III Trial Evaluating the Efficacy and Safety of BCI-ImmuneActivator Versus Adriamycin in BCG Refractory or Intolerant Patients With Carcinoma in Situ With or Without Resected Superficial Papillary Bladder Cancer
OBJECTIVES:
- Compare the efficacy of BCI-ImmuneActivator™ (keyhole limpet hemocyanin) versus
doxorubicin in BCG refractory or intolerant patients with carcinoma in situ with or
without resected superficial papillary bladder cancer.
- Compare the toxicity and safety of these treatments in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and prior BCG response (refractory vs intolerant). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive a sensitizing dose of keyhole limpet hemocyanin (KLH)
intradermally at week -2 followed by induction KLH IV once weekly at weeks 1-6.
Patients with partial or no response receive IV KLH reinduction therapy once weekly at
weeks 13-18. Patients with complete response receive IV KLH maintenance therapy monthly
at weeks 13, 17, and 21, and then at months 6-12.
- Arm II: Patients receive doxorubicin IV once weekly at weeks 1-6. Patients with
complete response receive maintenance therapy comprising doxorubicin IV at weeks 13,
17, and 21 and months 6-12.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1.5 years, and then every 6 months for 1 year.
(Patient total participation in this study may last as long as 42 months.)
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this
study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed carcinoma in situ of the bladder with or
without resected superficial papillary tumor
- Biopsy within 3 months of study with or without positive urinary cytology within
6 weeks of study
- Cystoscopy within 3 months of study
- Negative imaging study of the ureters and kidneys within 6 months of study
- BCG refractory disease
- Received and failed at least 1 prior induction course consisting of BCG weekly
for 6 weeks OR
- BCG intolerant
- Unable to receive an adequate course of intravesical BCG due to extreme toxicity
- Opted against or medically contraindicated to cystectomy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- WBC greater than 4,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 11 g/dL
Hepatic
- Bilirubin normal
- SGOT/SGPT normal
Renal
- Creatinine no greater than 1.5 times upper limit of normal
Cardiovascular
- No severe cardiovascular disease
Other
- No other severe disease
- No other malignancy within the past 5 years except basal or squamous cell skin cancer
or noninvasive cancer of the cervix
- No evidence of autoimmune disease, known immune deficiency, or immunosuppression
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior keyhole limpet hemocyanin immune activator
Chemotherapy
- No prior doxorubicin
- At least 3 months since prior mitomycin
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent steroids
Radiotherapy
- At least 4 months since prior radiotherapy
Surgery
- See Disease Characteristics
Other
- At least 4 weeks since prior intravesical therapy
- At least 3 months since prior investigational agents
- No concurrent cytotoxic immunosuppressive agents
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Michael G Hanna Jr., PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Intracel
Authority:
United States: Federal Government
Study ID:
INTRACEL-BCI-9804-04
NCT ID:
NCT00006034
Start Date:
June 1998
Completion Date:
March 2004
Related Keywords:
- Bladder Cancer
- stage 0 bladder cancer
- recurrent bladder cancer
- Urinary Bladder Neoplasms
Name | Location |
|---|---|
| Intracel Resources, LLC | Frederick, Maryland 21701 |
