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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

Thank you

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-ImmuneActivatorâ„¢ (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, LLCFrederick, Maryland  21701