![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00028652 |
RATIONALE: Inserting the gene for interleukin-12 into a person's skin tumor cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-12 gene therapy in treating patients who have skin metastases.
Condition | Intervention | Phase |
---|---|---|
Metastatic Cancer |
Drug: interleukin-12 gene |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial |
Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: Patients are stratified according to number of tumor sites (1 vs 2 vs 3 or more). Patients are assigned to 1 of 2 treatment arms.
Patients with stable or responding disease may receive 1 subsequent course beginning on day 29.
Patients are followed at 3, 6, and 12 months.
PROJECTED ACCRUAL: A total of 12 patients (6 per treatment group) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid malignancy
Tumor of at least 0.5 cm but no more than 2.5 cm infiltrating into or underlying the skin
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Study Chair: | David M. Mahvi, MD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000069115, WCCC-CO-9771, WCCC-HSC-1998-257, NCI-T98-0025 |
Study First Received: | January 4, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00028652 |
Health Authority: | United States: Federal Government |
skin metastases |
Interleukin-12 Neoplasm Metastasis |
Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Adjuvants, Immunologic Angiogenesis Inhibitors Pharmacologic Actions |
Neoplastic Processes Neoplasms Pathologic Processes Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |