Metastatic CancerPhase 1NCT00028652
Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases
A Phase 1 study testing interleukin-12 gene in people with Metastatic Cancer, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- interleukin-12 gene
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
About this study
Official title: Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial
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.
Read the 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.
- Conditions
- Metastatic Cancer
- Being tested
- interleukin-12 gene
- Keywords
- skin metastases
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interleukin-12 geneBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David M. Mahvi, MD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028652
- Sponsor's protocol ID
- CDR0000069115
- Other IDs
- P30CA014520, WCCC-CO-9771, WCCC-HSC-1998-257, NCI-T98-0025
- Status last verified
- Sep 2015
- First submitted
- 4 Jan 2002
- Last updated
- 13 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial
- ClinicalTrials.gov ID
- NCT00028652
- Acronym / sponsor ID
- CDR0000069115
- Conditions
- Metastatic Cancer
- Keywords
- skin metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2002
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interleukin-12 gene | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M. Mahvi, MD study chair
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing interleukin-12 gene in people with Metastatic Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.