Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases

NCT00028652 | Terminated Phase 1

• 5 other identifiers: CDR0000069115P30CA014520WCCC-CO-9771WCCC-HSC-1998-257NCI-T98-0025
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Cancer

Keywords

skin metastases

Interventions

interleukin-12 gene BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed solid malignancy * Surgically or medically incurable disease * No standard chemotherapy or radiotherapy exists for this disease * Tumor of at least 0.5 cm but no more than 2.5 cm infiltrating into or underlying the skin * Cutaneous metastases, subcutaneous metastases, or tumor-involved lymph nodes that are easily palpable PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * More than 3 months Hematopoietic: * WBC greater than 3,000/mm\^3 * Platelet count greater than 80,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL Renal: * Creatinine less than 2.0 mg/dL Other: * HIV negative * No active infections requiring antibiotic, antiviral, or antifungal treatment * No other active malignancy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 month since prior immunotherapy * No concurrent colony-stimulating factors Chemotherapy: * See Disease Characteristics * At least 1 month since prior chemotherapy Endocrine therapy: * At least 1 month since prior steroids (other than intermittent use as an antiemetic or topical agent) * No concurrent steroids Radiotherapy: * See Disease Characteristics * Prior radiotherapy to vaccine site allowed provided there is documentation of progressive disease Surgery: * See Disease Characteristics * No prior organ allografts Other: * No other concurrent antineoplastic therapy * No other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David M. Mahvi, MD

  University of Wisconsin, Madison

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Last Updated: December 13, 2019

Record last verified: 2015-09

Locations

US (1)