Keyhole Limpet Hemocyanin Compared With Doxorubicin in Treating Patients With Bladder Cancer

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether keyhole limpet hemocyanin is more effective than doxorubicin for bladder cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of keyhole limpet hemocyanin with that of doxorubicin in treating patients who have bladder cancer that has not responded to BCG or in those patients who cannot tolerate BCG.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intracel
• Treatments: Doxorubicin; Keyhole-limpet hemocyanin; Liposomal doxorubicin

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