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

This study is ongoing, but not recruiting participants.

First Received on December 21, 2007. Last Updated on February 17, 2011 History of Changes

Sponsor:	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:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treated	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:	Stephen B. Tucker, M.D., The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00581425 History of Changes
Other Study ID Numbers:	HSC-MS-06-0478, OSP-24412
Study First Received:	December 21, 2007
Last Updated:	February 17, 2011
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

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Imiquimod
Antiviral Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic
Interferon Inducers

ClinicalTrials.gov processed this record on February 12, 2012