Clinical trial NCT00082719: Short-Term Low-Dose Interferon Alfa in Treating Patients With Cancer of the Urothelium
Official title: Modulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bladder Cancer
Urethral Cancer
Keywords: stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
localized transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter
metastatic transitional cell cancer of the renal pelvis and ureter
anterior urethral cancer
posterior urethral cancer
urethral cancer associated with invasive bladder cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-05-19
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth of urothelial cancer.

PURPOSE: This randomized phase I trial is studying how well low-dose interferon alfa works in treating patients with cancer of the urothelium.

Detailed description: OBJECTIVES:

* Determine the modulation of apoptosis-related pathways in patients with cancer of the urothelium treated with short-term low-dose interferon alfa.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 4 treatment arms.

In all arms, treatment begins at the time of the pre-operative visit and continues until the time of cystoscopy.

* Arm I: Patients receive low-dose interferon alfa subcutaneously (SC) twice daily.
* Arm II: Patients receive interferon alfa as in arm I at a higher dose.
* Arm III: Patients receive interferon alfa SC once daily.
* Arm IV: Patients receive interferon alfa as in arm III at a higher dose. In all arms, treatment continues in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility criteria: Inclusion Criteria:

1. Patients must have histologically proven urothelial cancer, known or suspected (e.g. by outside evaluation) to be muscle-invasive, and be scheduled for cystoscopy and transurethral biopsy as part of their routine evaluation at M. D. Anderson.
2. Patients must understand the investigational nature of this study and provide written, informed consent.

Exclusion Criteria:

1. Patients who are pregnant or lactating are not eligible. Women of child-bearing potential must have a negative pregnancy test before starting therapy.
2. Patients with current symptoms suggestive of clinically significant affective disorder.
3. Patients taking more than physiologic replacement doses of corticosteroids are not eligible.

Primary outcomes:
measure: Descriptive Data on Expression of Death Effectors in Context of Low-dose Interferon
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ashish M. Kamat, MD
role: PRINCIPAL_INVESTIGATOR
References: