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Modulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon


Phase 1
N/A
N/A
Open (Enrolling)
Both
Bladder Cancer, Urethral Cancer

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Trial Information

Modulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Descriptive Data on Expression of Death Effectors in Context of Low-dose Interferon

Outcome Description:

Data collection continues with treatment in absence of unacceptable toxicity.

Outcome Time Frame:

2 Years

Safety Issue:

No

Principal Investigator

Ashish M. Kamat, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID03-0172

NCT ID:

NCT00082719

Start Date:

December 2003

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Urethral Cancer
  • 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
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms

Name

Location
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009