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NCT Number: NCT00082719

Short-Term Low-Dose Interferon Alfa in Treating Patients With Cancer of the Urothelium

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urethral Cancer Urethral Diseases Urethral Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients must understand the investigational nature of this study and provide written, informed consent.

Exclusion criteria

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

Treatment and study plan

recombinant interferon alfa

Biological

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

Arm I: Low-dose interferon alfa subcutaneously (SC) twice daily. Arm II: Interferon alfa as in arm I at a higher dose. Arm III: Interferon alfa SC once daily. Arm IV: Interferon alfa as in arm III at a higher dose.

Other names: Interferon Alfa 2b, Intron A

Primary outcomes

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

    Time frame: 2 Years

    Data collection continues with treatment in absence of unacceptable toxicity.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2015
Study completion
2015
First posted
May 19, 2004
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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