Intron-A/Aldara Combination Therapy for Basal Cell Carcinoma (BCC)

This study is ongoing, but not recruiting participants.

First Received: December 21, 2007 Last Updated: April 29, 2009 History of Changes

Sponsored by:	The University of Texas Health Science Center, Houston
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00581425

Purpose

A trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara.

Condition	Intervention	Phase
Basal Cell Carcinoma	Biological: Imiquimod and Interferon alpha	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Intron-A/Aldara Combination Therapy for BCC Excluding the Face and Scalp

Resource links provided by NLM:

Drug Information available for: Interferon alfa-2a S 26308 Interferon alfa-2b Interferon alfa-n1 Interferons

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

resolution of basal cell carcinoma [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

resolution of basal cell carcinoma at a lower cost and less inflammation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	49
Study Start Date:	December 2007
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treated: Experimental	Biological: Imiquimod and Interferon alpha Imiquimod first two weeks and last two weeks. Interferon middle five weeks.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Nodular or superficial basal cell carcinoma on the skin excluding scalp or face

Exclusion Criteria:

Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581425

Locations

United States, Texas
University of Texas Health Science Center of Houston Dermatology Clinic
Houston, Texas, United States, 77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator:

Stephen B Tucker, M.D.

University of Texas Health Science Center of Houston Dermatology Clinic

More Information

No publications provided

Responsible Party:	The University of Texas Health Science Center, Houston ( Stephen B. Tucker, M.D. )
Study ID Numbers:	HSC-MS-06-0478, OSP-24412
Study First Received:	December 21, 2007
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00581425 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:

BCC
Basal Cell Carcinoma
Intron-A
Aldara
Basal Cell Carcinoma excluding scalp and face

Study placed in the following topic categories:

Interferon-alpha
Facies
Immunologic Factors
Interferons
Adjuvants, Immunologic
Carcinoma, Basal Cell
Imiquimod

Antiviral Agents
Angiogenesis Inhibitors
Carcinoma
Neoplasms, Basal Cell
Interferon Alfa-2a
Interferon Alfa-2b
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Interferon-alpha
Interferon Inducers
Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Growth Substances
Interferons
Physiological Effects of Drugs
Adjuvants, Immunologic
Carcinoma, Basal Cell
Imiquimod

Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Therapeutic Uses
Neoplasms, Basal Cell
Growth Inhibitors
Angiogenesis Modulating Agents
Interferon Alfa-2a
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 06, 2009