Breast CancerPhase 1NCT00301106
Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver
A Phase 1 study testing adenovirus-mediated human interleukin-12 in people with Breast Cancer and Metastatic Cancer, run by Max Sung at 1 site in United States.
Trial summary
RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of a gene-modified virus that can make interleukin-12 in treating women with breast… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer, Metastatic Cancer
- What is being tested?
- adenovirus-mediated human interleukin-12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Aug 2008
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed* breast adenocarcinoma metastatic to the liver
- Solitary or multiple hepatic metastases
- No malignant involvement of > 40% of the estimated liver volume NOTE: *Must be from the hepatic tumor designated for study injection
- Metastatic liver tumors must be measurable in ≥ 2 dimensions on CT scan or MRI
- At least 1 metastatic hepatic tumor ≥ 2 cm in diameter must be visualized by ultrasound and accessible for percutaneous injection under ultrasound guidance
- Extrahepatic metastasis allowed
- No solitary hepatic metastasis eligible for liver resection
- No clinical evidence for severe liver disease (e.g., prior or current ascites or portosystemic encephalopathy)
- Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Granulocyte count ≥ 1,500/mm^3
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100,000/mm^3
- PT ≤ 14.5 sec
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- Transaminases ≤ 2.5 times ULN
- Karnofsky performance status ≥ 70%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 2 months after completion of study treatment
- No active infection or serious intercurrent medical illness
- No HIV infection
- Life expectancy ≥ 16 weeks
- No other malignancy within the past 5 years except inactive nonmelanoma skin cancer, in situ carcinoma of the cervix, or grade 1 papillary bladder cancer
- At highest dose level, patient must weigh ≥ 30 kg
PRIOR CONCURRENT THERAPY:
- No systemic immunosuppressive drugs, including corticosteroids, within 2 months prior to study entry
- Not require immunosuppressive drugs or anticoagulant therapy with heparin or warfarin for at least 2 months after study treatment
- No chemotherapy within 4 weeks of study entry (6 weeks for nitrosoureas)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
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 Patients With Metastatic Breast Cancer to the Liver
RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of a gene-modified virus that can make interleukin-12 in treating women with breast cancer that has spread to the liver.
Read the detailed description
Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene (Adv.RSV-hIL12, also termed ADV-hIL-12).
OBJECTIVES:
- Study the toxicity of escalating doses of adenoviral vector expressing the human recombinant interleukin-12 gene, administered by percutaneous intratumoral injection, in women with liver metastasis secondary to breast cancer.
- Determine tumor responses produced by this regimen.
- Determine immune responses induced by this regimen.
- Conditions
- Breast Cancer, Metastatic Cancer
- Being tested
- adenovirus-mediated human interleukin-12
- Keywords
- stage IV breast cancer, liver metastases
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
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.
Toxicity
Serial monitoring of tumor necrosis factor alpha (TNFα) levels
Measured: up to 15 days
Secondary outcomes (4)
Tumor Response
Sequential assessment of tumor on CT or MRI
Measured: up to 2 months
IL12 level Immune response
Serum IL12 level
Measured: up to 2 months
IFNγ levels Immune response
IFNγ levels
Measured: up to 2 months
Immune response
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 posted10 Mar 2006 (estimated)
- Study startOct 2005
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: protocol underwent significant revisions, decision made to terminate study and open as new study listed NCT00849459
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
- 2 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, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301106
- Sponsor's protocol ID
- GCO 97-779
- Other IDs
- MTS-GCO-97-779, MTS-9911-358, MTS-A-8200, CDR0000456626
- Status last verified
- Jan 2017
- First submitted
- 8 Mar 2006
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 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 Patients With Metastatic Breast Cancer to the Liver
- ClinicalTrials.gov ID
- NCT00301106
- Acronym / sponsor ID
- GCO 97-779
- Conditions
- Breast Cancer, Metastatic Cancer
- Keywords
- stage IV breast cancer, liver metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: protocol underwent significant revisions, decision made to terminate study and open as new study listed NCT00849459
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Max SungUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 10 Mar 2006 (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: Biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of a gene-modified virus that can make interleukin-12 in treating women with breast cancer that has spread to the liver.
Detailed description
Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene (Adv.RSV-hIL12, also termed ADV-hIL-12).
OBJECTIVES:
- Study the toxicity of escalating doses of adenoviral vector expressing the human recombinant interleukin-12 gene, administered by percutaneous intratumoral injection, in women with liver metastasis secondary to breast cancer.
- Determine tumor responses produced by this regimen.
- Determine immune responses induced by this regimen.
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 to 85 years
- 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
Toxicity
Time frame: up to 15 days
Serial monitoring of tumor necrosis factor alpha (TNFα) levels
4 secondary outcomes
Tumor Response
Time frame: up to 2 months
IL12 level Immune response
Time frame: up to 2 months
IFNγ levels Immune response
Time frame: up to 2 months
Immune response
Time frame: up to 2 months
Results and safety
The study was stopped early (reason given: protocol underwent significant revisions, decision made to terminate study and open as new study listed NCT00849459). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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 study chair
Icahn School of Medicine 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 and Metastatic 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: stopped early, as of the sponsor's last update on 2 Feb 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 was stopped early (reason given: protocol underwent significant revisions, decision made to terminate study and open as new study listed NCT00849459). 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.
What does the primary outcome measure?
Toxicity (time frame: up to 15 days). 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 2 Feb 2017.