Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases

Metastatic Cancer Clinical Trial

Official title:

Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00028652
• Other study ID #: CDR0000069115
• Secondary ID: P30CA014520WCCC-
• Status: Terminated
• Phase: Phase 1
• Start date: January 2002

Study information

• Verified date: September 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Biological:
• interleukin-12 gene

Locations

Country	Name	City	State
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,