Breast CancerPhase 1NCT00849459
Gene Therapy in Treating Women With Metastatic Breast Cancer
A Phase 1 study testing adenovirus-mediated human interleukin-12 in people with Breast Cancer, run by Max Sung at 1 site in United States.
Trial summary
RATIONALE: Placing the gene for interleukin-12 into breast cancer cells may help the body build an immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in treating women with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- adenovirus-mediated human interleukin-12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jun 2011
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
- Malignant disease in the skin, chest wall, or other sites (lymph nodes or primary tumor in the breast) accessible to percutaneous needle placement and injection
- Solitary or multiple tumors
- Measurable disease in ≥ 2 dimensions by physical examination or CT/MRI scan
- Malignant tumors in the skin and chest wall must be ≥ 4 mm in diameter by physical examination
- Malignant tumors in other accessible sites must be ≥ 1 cm in diameter on physical examination
- Malignant disease in other organs (in addition to skin or chest wall metastases) allowed
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Karnofsky performance status 70-100%
- Life expectancy ≥ 16 weeks
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 mg/dL
- PT normal
- Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min
- Serum total bilirubin ≤ 2.0 times upper limit of normal (ULN)
- Serum transaminases ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Weight ≥ 30 kg (for patients treated with the highest dose level of study drug)
- No active infection or concurrent serious medical illness
- No HIV positivity
- No other malignancy within the past 5 years except for the following:
- Inactive nonmelanoma skin cancer
- In situ carcinoma of the cervix
- Grade 1 papillary bladder cancer
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- No anticoagulant therapy with heparin or warfarin for ≥ 2 months after completion of study treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn Medical Center at Mount Sinai
New York, New York, 10029
About this study
Official title: Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer
RATIONALE: Placing the gene for interleukin-12 into breast cancer cells may help the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in treating women with metastatic breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the toxicity and maximum tolerated dose of intratumoral injection of adenovirus-mediated human interleukin-12 gene in women with metastatic breast cancer.
- Determine the tumor response in patients treated with this regimen.
- Determine the immune response in patients treated with this regimen.
OUTLINE: Patients receive a single dose of adenovirus-mediated human interleukin-12 intratumorally via percutaneous needle placement under ultrasound guidance.
Blood and tumor tissue samples are collected periodically for immunological laboratory studies. Samples are analyzed for serum cytokine levels by ELISA; qualitative analysis of immune biomarkers by IHC staining; and immune cell biomarker analysis by FACS.
After completion of study therapy, patients are followed periodically.
- Conditions
- Breast Cancer
- Being tested
- adenovirus-mediated human interleukin-12
- Keywords
- recurrent breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adenovirus-mediated human interleukin-12Biological
The purified ADV-hIL12 is suspended in formulation buffer (10mM Tris, pH 7.5/
1mM MgCl2/ 150mM NaCl/ 10% glycerol) and aliquoted into 1ml cryovials. The filled vials are stored at or below -60 degC.
| Study group | Role | What they receive |
|---|---|---|
| adenovirus-mediated human interleukin-12 | Experimental | starting dose of ADV-hIL12 - 1 x 10 to the 10th power vp (virus particles) per patient, escalating in half-log increments up to 1 x 10 to the 13th power vp per patient, after which dose escalation will be at lower increments of 2 x 10 to the 13th power vp, to a maximum of 3.0 x 10 to the 13th power vp per patient. Receives: Biological: adenovirus-mediated human interleukin-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Serum antibodies (titer) to adenovirus
Measured: up to 1 month
Toxicity and safety
adverse events as assessed by NCI CTCAE v3.0
Measured: up to 2 months
Secondary outcomes (2)
Tumor response progression)
Sequential assessment of tumor on CT or MRI (complete response, partial response, stable disease, or disease)
Measured: up to 2 months
Immune response
Serum IL12, and IFNγ levels. Serum antibodies (titer) to adenovirus.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Sung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Max Sung, Icahn School of Medicine at Mount Sinai
- Investigators
- Max W. Sung, MD, Principal investigator, Icahn Medical Center at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849459
- Sponsor's protocol ID
- GCO 02-0797
- Other IDs
- MTS-GCO-02-0797, NIH-0707-869, CDR0000629819
- Status last verified
- Jan 2017
- First submitted
- 20 Feb 2009
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00849459
- Acronym / sponsor ID
- GCO 02-0797
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IV breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Max SungUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Feb 2009 (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: Placing the gene for interleukin-12 into breast cancer cells may help the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in treating women with metastatic breast cancer.
Detailed description
OBJECTIVES:
- Determine the toxicity and maximum tolerated dose of intratumoral injection of adenovirus-mediated human interleukin-12 gene in women with metastatic breast cancer.
- Determine the tumor response in patients treated with this regimen.
- Determine the immune response in patients treated with this regimen.
OUTLINE: Patients receive a single dose of adenovirus-mediated human interleukin-12 intratumorally via percutaneous needle placement under ultrasound guidance.
Blood and tumor tissue samples are collected periodically for immunological laboratory studies. Samples are analyzed for serum cytokine levels by ELISA; qualitative analysis of immune biomarkers by IHC staining; and immune cell biomarker analysis by FACS.
After completion of study therapy, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adenovirus-mediated human interleukin-12 | Experimental | Biological: adenovirus-mediated human interleukin-12starting dose of ADV-hIL12 - 1 x 10 to the 10th power vp (virus particles) per patient, escalating in half-log increments up to 1 x 10 to the 13th power vp per patient, after which dose escalation will be at lower increments of 2 x 10 to the 13th power vp, to a maximum of 3.0 x 10 to the 13th power vp per patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- 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 |
|---|---|---|
| adenovirus-mediated human interleukin-12The purified ADV-hIL12 is suspended in formulation buffer (10mM Tris, pH 7.5/ 1mM MgCl2/ 150mM NaCl/ 10% glycerol) and aliquoted into 1ml cryovials. The filled vials are stored at or below -60 degC. | Biological | adenovirus-mediated human interleukin-12 |
Primary outcome
Maximum tolerated dose
Time frame: up to 1 month
Serum antibodies (titer) to adenovirus
Toxicity and safety
Time frame: up to 2 months
adverse events as assessed by NCI CTCAE v3.0
2 secondary outcomes
Tumor response progression)
Time frame: up to 2 months
Immune response
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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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.
Max W. Sung, MD principal investigator
Icahn Medical Center at Mount Sinai
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 adenovirus-mediated human interleukin-12 in people with Breast Cancer, run by Max Sung 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: finished, as of the sponsor's last update on 11 Jan 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Maximum tolerated dose (time frame: up to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 11 Jan 2017.