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

This study is currently recruiting participants.

Verified by The University of Texas Health Science Center, Houston, July 2008

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

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

U.S. FDA Resources

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

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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2008 (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

Contacts

Contact: Stephen B Tucker, M.D.

281-773-6774

stephen.b.tucker@uth.tmc.edu

Locations

United States, Texas
University of Texas Health Science Center of Houston Dermatology Clinic	Recruiting
Houston, Texas, United States, 77030
Contact: Stephen B Tucker, M.D. 281-773-6774 stephen.b.tucker@uth.tmc.edu

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

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:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00581425
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
Interferons
Imiquimod
Carcinoma, Basal Cell

Interferon Alfa-2a
Interferon Alfa-2b
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Interferon Inducers
Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Adjuvants, Immunologic

Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Neoplasms, Basal Cell
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 13, 2009