search
Back to results

Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases

Primary Purpose

Metastatic Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
interleukin-12 gene
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring skin metastases

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 4, 2002
Last Updated
December 12, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00028652
Brief Title
Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases
Official Title
Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Determine the safety and toxicity of interleukin-12 gene in patients with spontaneous skin metastases. Determine the antitumor immune response in patients treated with this regimen. Compare the toxicity of this regimen administered for 1 week vs 2 weeks in these patients. Compare the local and systemic antitumor response in patients treated with this regimen administered for 1 week vs 2 weeks. 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. Group A: Patients receive interleukin-12 gene intratumorally over 5 minutes on days 1, 3, and 5. Group B: Patients receive IL-12 gene intratumorally over 5 minutes on days 1, 3, 5, 8, 10, and 12. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
skin metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
interleukin-12 gene

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M. Mahvi, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases

We'll reach out to this number within 24 hrs