Breast CancerPhase 1NCT00003002
HER-2/Neu Vaccine Plus GM-CSF in Treating Patients With Stage III or Stage IV Breast, Ovarian, or Non-small Cell Lung Cancer
A Phase 1 study testing HER-2/neu peptide vaccine and sargramostim in people with Breast Cancer and Lung Cancer, run by University of Washington at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from the HER2/neu antigen may make the body build an immune response and kill tumor cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow or peripheral blood. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Breast Cancer, Lung Cancer, Ovarian Cancer
- What is being tested?
- HER-2/neu peptide vaccine and sargramostim
- Type of treatment
- Vaccines
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1996to Jan 2004
- 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 Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven stage III or IV breast, ovarian, or nonsmall cell lung cancer (NSCLC): Adenocarcinoma No progressive disease May have comlpeted at least 1 standard chemotherapy regimen Confirmed HER-2/neu protein overexpression in tumor (either primary tumor or metastasis)
PATIENT CHARACTERISTICS: Age: Pre or postmenopausal Performance status: Not specified Life expectancy: At least 12 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL Creatinine clearance greater than 60 mL/min Other: No anergy (positive delayed type hypersensitivity response required to two or more common recall antigens) Female patients must be nonfertile Male patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 1 month since cytotoxic chemotherapy Endocrine therapy: At least 1 month since corticosteroid therapy Concurrent hormone therapy allowed Radiotherapy: Concurrent radiation therapy for local control of disease allowed (except as initial therapy for NSCLC) Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School of Medicine
Seattle, Washington, 98195
About this study
Official title: A Phase I Study of a HER-2/Neu Peptide Based Vaccine With GM-CSF as an Adjuvant in Patients With Advanced Stage HER-2/Neu Expressing Cancers
RATIONALE: Vaccines made from the HER2/neu antigen may make the body build an immune response and kill tumor cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow or peripheral blood.
PURPOSE: Phase I trial to study the effectiveness of HER-2/neu vaccine plus GM-CSF in treating patients who have stage III or stage IV breast cancer, stage III or stage IV ovarian cancer, or stage III or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES: I. Determine the safety of serial intradermal vaccinations of HER-2/neu derived peptides with sargramostim (GM-CSF) as an adjuvant in patients with stage III or IV HER-2/neu expressing breast, ovarian, or nonsmall cell lung cancer. II. Determine whether immunity can be elicited with peptides derived from the intracellular domain of the HER-2/neu protein. III. Determine whether immunity can be elicited with peptides derived from the extracellular domain of the HER-2/neu protein. IV. Determine whether cytotoxic T cells specific for the HER-2/neu protein can be elicited in patients with HLA-A2 by immunization with peptides derived from the HER-2/neu protein.
OUTLINE: Patients receive one of three HER-2/neu peptide vaccine formulations that also contain sargramostim (GM-CSF) as the vaccine adjuvant. Each vaccine is studied in 20 patients. A maximum of 3 patients receive a vaccine each month for 6 months to monitor the potential toxicity associated with sequential immunizations. Patients receive a follow-up evaluation 1 month after the last vaccination. Those patients who have an immune response related to the vaccine will continue to have immunologic evaluations performed every 2 months while immune responses can still be detected.
PROJECTED ACCRUAL: 60 patients will be accrued.
- Conditions
- Breast Cancer, Lung Cancer, Ovarian Cancer
- Being tested
- HER-2/neu peptide vaccine, sargramostim
- Keywords
- stage III breast cancer, stage IV breast cancer, stage III non-small cell lung cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Ovarian Epithelial, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER-2/neu peptide vaccineBiological
sargramostimBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2004 (estimated)
- Study startApr 1996
- Primary completionJan 2004
- Study completionJan 2004
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.
- More trials run by University of WashingtonThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary (Nora) L. Disis, MD, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003002
- Sponsor's protocol ID
- 14798
- Other IDs
- UW-100.1, NCI-V97-1259
- Status last verified
- Feb 2019
- First submitted
- 1 Nov 1999
- Last updated
- 27 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of a HER-2/Neu Peptide Based Vaccine With GM-CSF as an Adjuvant in Patients With Advanced Stage HER-2/Neu Expressing Cancers
- ClinicalTrials.gov ID
- NCT00003002
- Acronym / sponsor ID
- 14798
- Conditions
- Breast Cancer, Lung Cancer, Ovarian Cancer
- Keywords
- stage III breast cancer, stage IV breast cancer, stage III non-small cell lung cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Apr 1996
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 30 Jul 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 the HER2/neu antigen may make the body build an immune response and kill tumor cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow or peripheral blood.
PURPOSE: Phase I trial to study the effectiveness of HER-2/neu vaccine plus GM-CSF in treating patients who have stage III or stage IV breast cancer, stage III or stage IV ovarian cancer, or stage III or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES: I. Determine the safety of serial intradermal vaccinations of HER-2/neu derived peptides with sargramostim (GM-CSF) as an adjuvant in patients with stage III or IV HER-2/neu expressing breast, ovarian, or nonsmall cell lung cancer. II. Determine whether immunity can be elicited with peptides derived from the intracellular domain of the HER-2/neu protein. III. Determine whether immunity can be elicited with peptides derived from the extracellular domain of the HER-2/neu protein. IV. Determine whether cytotoxic T cells specific for the HER-2/neu protein can be elicited in patients with HLA-A2 by immunization with peptides derived from the HER-2/neu protein.
OUTLINE: Patients receive one of three HER-2/neu peptide vaccine formulations that also contain sargramostim (GM-CSF) as the vaccine adjuvant. Each vaccine is studied in 20 patients. A maximum of 3 patients receive a vaccine each month for 6 months to monitor the potential toxicity associated with sequential immunizations. Patients receive a follow-up evaluation 1 month after the last vaccination. Those patients who have an immune response related to the vaccine will continue to have immunologic evaluations performed every 2 months while immune responses can still be detected.
PROJECTED ACCRUAL: 60 patients will be accrued.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| HER-2/neu peptide vaccine | Biological | – |
| sargramostim | Biological | – |
Primary outcome
Not reported in the source record.
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 27 Feb 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.
Mary (Nora) L. Disis, MD study chair
University of Washington
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 HER-2/neu peptide vaccine and sargramostim in people with Breast Cancer and Lung Cancer, run by University of Washington 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 27 Feb 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 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.
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 27 Feb 2019.