Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases
NCT ID: NCT00028652
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
INTERVENTIONAL
2002-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Phase I trial to study the effectiveness of interleukin-12 gene therapy in treating patients who have skin metastases.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
interleukin-12 gene
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David M. Mahvi, MD
Role: STUDY_CHAIR
University of Wisconsin, Madison
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WCCC-CO-9771
Identifier Type: -
Identifier Source: secondary_id
WCCC-HSC-1998-257
Identifier Type: -
Identifier Source: secondary_id
NCI-T98-0025
Identifier Type: -
Identifier Source: secondary_id
CDR0000069115
Identifier Type: -
Identifier Source: org_study_id