Breast CancerPhase 1/2NCT00095862
Vaccine Therapy in Treating Patients With HER2/Neu Positive or Negative Stage IV Breast Cancer or Other HER2/Neu Positive Cancers
A Phase 1/2 study testing allogeneic GM-CSF-secreting breast cancer vaccine, recombinant interferon alfa and cyclophosphamide in people with Breast Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Wiseman Research Initiatives LLC at 3 sites in United States.
Trial summary
RATIONALE: Vaccines made from gene-modified tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- allogeneic GM-CSF-secreting breast cancer vaccine, recombinant interferon alfa and cyclophosphamide
- Type of treatment
- Vaccines
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2004to not given
- Phase
- Phase 1/2
- 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 breast cancer meeting 1 of the following criteria:
- Recurrent and/or metastatic lesions that are HER2/neu-positive or negative
- Recurrent or progressive cancer of the lung, ovary, pancreas, prostate, bladder, or other primary site associated with HER2/neu-positive tumor by histochemistry
- Bone-only metastatic breast cancer, cytologically confirmed malignant effusions, histologically confirmed marrow involvement, or other evaluable (but non-measurable) metastatic disease allowed
- Failed prior first-line chemotherapy (e.g., anthracycline- or taxane-based therapy) with or without adjuvant chemotherapy or hormonal therapy
- No curative or reliably effective palliative surgery, radiotherapy, or medical therapy available
- Stable brain metastases allowed provided the following criteria are met*:
- Previously treated
- No concurrent requirement for corticosteroids
- No radiological or clinical deterioration within the past 6 weeks NOTE: *Patients who had recent treatment with gamma knife or intensity-modulated radiotherapy for brain metastases are eligible provided there has been recovery from known or anticipated toxic effects
- Patients with no HLA-A2 allele are eligible
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female or male
Menopausal status
- Not specified
Performance status
- ECOG 0-2
Life expectancy
- At least 4 months
Hematopoietic
- Absolute granulocyte count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 2 mg/dL
- Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
- ALT and AST ≤ 2 times ULN
Renal
- BUN ≤ 30 mg/dL
- Creatinine ≤ 2 mg/dL
- ≤ 1 g protein on 24-hour urine collection OR
- ≤ 1+ proteinuria on urinalysis
Cardiovascular
- Hypertension controlled by agents (except beta-blockers) allowed
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No history of anaphylactic reaction to any known or unknown antigen
- No history of clinical hypersensitivity to sargramostim (GM-CSF), interferon, yeast, beef, or to any components used in preparation of study vaccine
- No clinical or laboratory features indicative of AIDS
- No rheumatological, psychiatric, or other clinically progressive major medical problems requiring treatment
- No other malignancy within the past 2 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 3 weeks since prior biological therapy, including trastuzumab (Herceptin^®)
- More than 3 weeks since prior immunotherapy
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- More than 3 weeks since prior chemotherapy (8 weeks for nitrosoureas or mitomycin)
- No concurrent chemotherapy
Endocrine therapy
- See Disease Characteristics
- More than 3 weeks since prior hormonal therapy
- No concurrent hormonal therapy
- No concurrent systemic steroids
- Concurrent inhalation steroids for respiratory hypersensitivity (e.g., triamcinolone nasal or pulmonary inhalers) allowed
Radiotherapy
- See Disease Characteristics
- More than 3 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- More than 3 weeks since prior major surgery with general anesthesia
- No concurrent major surgery
Other
- Recovered from prior therapy
- Patients receiving pamidronate, bisphosphonates, or other supportive measures must continue therapy during study participation
- No concurrent anticoagulants
- No concurrent beta-blockers for control of mild hypertension or other indications
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, 91204
Hollywood Presbyterian Medical Center
Los Angeles, California, 90027-0902
Study site
Los Angeles, California, 90057
About this study
Official title: A Phase 1-2 Study for Stage IV Breast and HER2/Neu Positive Cancers to Evaluate the Safety and Efficacy of a Vaccine Using Whole Cells From the SVBR- 1-GM Cell Line Genetically Engineered To Produce Granulocyte- Macrophage Colony Stimulating Factor
RATIONALE: Vaccines made from gene-modified tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Combining vaccine therapy with cyclophosphamide and interferon alfa may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with interferon alfa and cyclophosphamide in treating patients who have stage IV breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the safety, tolerability, and feasibility of vaccine therapy comprising an allogeneic (non-self) tumor cell line transfected with the sargramostim (GM-CSF) gene combined with low-dose interferon alfa and low-dose cyclophosphamide in patients with stage IV breast cancer or other solid tumors.
- Determine the clinical response, time to progression, and survival of patients treated with this regimen.
- Correlate clinical response with immunological response in patients treated with this regimen.
OUTLINE: Patients receive low-dose cyclophosphamide IV once 2-3 days before each tumor vaccine. Patients then receive tumor vaccine comprising HER2/neu-positive allogeneic (non-self) breast cancer cells transfected with the sargramostim (GM-CSF) gene intradermally (ID) on day 1. Patients also receive low-dose interferon alfa ID approximately 48 and 96 hours after each tumor vaccine. Treatment repeats every 2 weeks for 3 vaccinations and then monthly for 3 vaccinations in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.
- Being tested
- allogeneic GM-CSF-secreting breast cancer vaccine, recombinant interferon alfa, cyclophosphamide
- Keywords
- recurrent breast cancer, stage IV breast cancer, male breast cancer, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic GM-CSF-secreting breast cancer vaccineBiological
recombinant interferon alfaBiological
cyclophosphamideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability, and feasibility
Clinical response
Time to progression
Survival
Correlation of clinical response with immunological response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2004 (estimated)
- Study startNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wiseman Research Initiatives LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charles L. Wiseman, MD, FACP, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095862
- Sponsor's protocol ID
- CDR0000393552
- Other IDs
- WRI-GEV-007
- Status last verified
- Oct 2011
- First submitted
- 9 Nov 2004
- Last updated
- 5 Feb 2018
- Results posted
- No
Publications
Lacher MD, Bauer G, Fury B, Graeve S, Fledderman EL, Petrie TD, Coleal-Bergum DP, Hackett T, Perotti NH, Kong YY, Kwok WW, Wagner JP, Wiseman CL, Williams WV. SV-BR-1-GM, a Clinically Effective GM-CSF-Secreting Breast Cancer Cell Line, Expresses an Immune Signature and Directly Activates CD4+ T Lymphocytes. Front Immunol. 2018 May 15;9:776. doi: 10.3389/fimmu.2018.00776. eCollection 2018.
PubMed 29867922
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1-2 Study for Stage IV Breast and HER2/Neu Positive Cancers to Evaluate the Safety and Efficacy of a Vaccine Using Whole Cells From the SVBR- 1-GM Cell Line Genetically Engineered To Produce Granulocyte- Macrophage Colony Stimulating Factor
- ClinicalTrials.gov ID
- NCT00095862
- Acronym / sponsor ID
- CDR0000393552
- Keywords
- recurrent breast cancer, stage IV breast cancer, male breast cancer, unspecified adult solid tumor, protocol specific
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Wiseman Research Initiatives LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- First posted
- 9 Nov 2004 (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: Vaccines made from gene-modified tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Combining vaccine therapy with cyclophosphamide and interferon alfa may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with interferon alfa and cyclophosphamide in treating patients who have stage IV breast cancer.
Detailed description
OBJECTIVES:
- Determine the safety, tolerability, and feasibility of vaccine therapy comprising an allogeneic (non-self) tumor cell line transfected with the sargramostim (GM-CSF) gene combined with low-dose interferon alfa and low-dose cyclophosphamide in patients with stage IV breast cancer or other solid tumors.
- Determine the clinical response, time to progression, and survival of patients treated with this regimen.
- Correlate clinical response with immunological response in patients treated with this regimen.
OUTLINE: Patients receive low-dose cyclophosphamide IV once 2-3 days before each tumor vaccine. Patients then receive tumor vaccine comprising HER2/neu-positive allogeneic (non-self) breast cancer cells transfected with the sargramostim (GM-CSF) gene intradermally (ID) on day 1. Patients also receive low-dose interferon alfa ID approximately 48 and 96 hours after each tumor vaccine. Treatment repeats every 2 weeks for 3 vaccinations and then monthly for 3 vaccinations in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 |
|---|---|---|
| allogeneic GM-CSF-secreting breast cancer vaccine | Biological | – |
| recombinant interferon alfa | Biological | – |
| cyclophosphamide | Drug | – |
Primary outcome
Safety, tolerability, and feasibility
Clinical response
Time to progression
Survival
Correlation of clinical response with immunological response
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 5 Feb 2018.
- Derived from this study: PubMed 29867922Lacher MD, Bauer G, Fury B, Graeve S, Fledderman EL, Petrie TD, Coleal-Bergum DP, Hackett T, Perotti NH, Kong YY, Kwok WW, Wagner JP, Wiseman CL, Williams WV. SV-BR-1-GM, a Clinically Effective GM-CSF-Secreting Breast Cancer Cell Line, Expresses an Immune Signature and Directly Activates CD4+ T Lymphocytes. Front Immunol. 2018 May 15;9:776. doi: 10.3389/fimmu.2018.00776. eCollection 2018.
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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.
Charles L. Wiseman, MD, FACP study chair
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing allogeneic GM-CSF-secreting breast cancer vaccine, recombinant interferon alfa and cyclophosphamide in people with Breast Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Wiseman Research Initiatives LLC at 3 sites 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Safety, tolerability, and feasibility. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00095862, which also lists 1 linked publication.
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 5 Feb 2018.