Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over NBCG-17

Objectives

I.  Evaluate the toxicity of intravesical beta-interferon in patients with 
superficial transitional cell carcinoma of the bladder who have previously 
failed to respond to intravesical chemotherapy.
II.  Evaluate the therapeutic efficacy of beta-interferon in these patients.
III.  Study the biologic disposition of intravesical beta-interferon.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients aged 18 years and older with 
histologically proven primary bladder carcinoma Grade I-III, staged as Ta or 
TIS no more than 4 weeks prior to entry, provided they have failed (endoscopic 
documentation required) on up to but not exceeding 2 different previous 
intravesical chemotherapies.  The following patients are eligible:  those with 
superficial tumor persisting in the bladder after at least 4 instillations of 
standard cytotoxic intravesical therapy (thiotepa or adriamycin or 
mitomycin-C); those with recurrence of tumor after successful treatment with 
intravesical therapy during monthly maintenance therapy; those who never 
received thiotepa ablative therapy but who were placed on monthly prophylaxis 
with thiotepa (15-60 mg) and subsequently developed tumor during monthly 
maintenance; those who have failed on 1 or 2 different intravesical cytotoxic 
drugs (e.g., patients failing TTPA only are eligible as are those failing TTPA 
and mitomycin-C or TTPA and adriamycin); and those who have never received any 
intravesical chemotherapy, as long as they meet all other eligibility 
requirements.  In patients with single tumors, the maximum tumor diameter must 
be at least 2 cm.  Patients may not have received intravesical or systemic 
therapy with BCG or interferon of any kind and may not have received more than 
2 different intravesical cytotoxic drugs.  The expected survival must be at 
least 3 months and the ECOG performance status must be 0 or 1.  Liver, kidney, 
and bone marrow function must be adequate.  There may have been no treatment 
with thiotepa or mitomycin-C within 4 weeks of entry and no radiotherapy or 
treatment with glucocorticosteroids within 2 weeks of entry.  At the time of 
entry, tumor stage must not be T1 or greater; there must have been no muscle 
invasion (Stage T2+ disease) within 2 years of entry.  Pregnant or lactating 
females will be excluded, and women of childbearing age should be advised to 
take precautions to prevent pregnancy during treatment.  The bladder capacity 
must be at least 100 ml, and there may be no evidence of urinary 
extravasation.  Patients must demonstrate no evidence of side effects of 
previous systemic antineoplastic therapy.  There may be no New York Heart 
Association Classification III or IV cardiac disease, and patients may not 
have unstable angina pectoris or other heart disease requiring treatment with 
antiarrhythmic drugs such as procainamide, quinidine, or disopyramide; 
treatment with digitalis is allowed.  There must be no medical or psychiatric 
contraindication to intravesical treatment.

Expected Enrollment

Four patients will be entered successively at each dosage level until 
development of grade III or IV toxicity.

Outline

Nonrandomized study.
Immunotherapy.  Beta-Interferon, NSC-352291.

Trial Contact Information

Trial Lead Organizations

National Bladder Cancer Collaborative Group

Kenneth Blance Cummings, MD, Protocol chair		Ph: 908-235-7775