Breast CancerPhase 1NCT00005023
Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV 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 may make the body build an immune response to tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Read more about this study
- Who is it for?
- Ages 18 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
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Jan 2001
- 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: Stage III adenocarcinoma that overexpresses HER-2 and previously treated by surgical resection, conventional chemotherapy, or radiotherapy OR Stage IV adenocarcinoma that overexpresses HER-2 and in stable or complete remission with no other concurrent chemotherapy Must have documented HER-2 protein overexpression in the primary or metastatic tumor HLA-A2 positive
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 90-100% 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 OR Creatinine clearance greater than 60 mL/min Other: Female patients must have completed childbearing Fertile male patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since prior corticosteroids Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No other concurrent investigational phase I studies
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 Vaccine Trial of a HER-2/Neu Peptide Incorporated Into PLG Microspheres in Patients With Advanced Stage HER2-Expressing Cancers
RATIONALE: Vaccines may make the body build an immune response to tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have stage III or stage IV cancer.
Read the detailed description
OBJECTIVES: I. Determine the safety of serial intradermal or subcutaneous vaccinations of HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide (PLG) microspheres with adjuvant sargramostim (GM-CSF) in patients with stage III or IV HER-2 expressing cancers. II. Determine whether cytotoxic T lymphocytes (CTL) specific for the HER-2 protein can be elicited in patients with HLA-A2 by immunization with this regimen. III. Determine which route of immunization, intradermal or subcutaneous, is more effective in generating HER-2 specific CTL in these patients on this regimen. IV. Determine the extent to which escalated dose of PLG peptide affects the immune response in these patients on this regimen.
OUTLINE: Patients undergo leukapheresis prior to study and after final vaccination. Patients are sequentially entered into one of three treatment arms: Arm I: Patients receive an intradermal vaccination of HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide (PLG) microspheres with adjuvant sargramostim (GM-CSF). Arm II: Patients receive a subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG microspheres with adjuvant GM-CSF. Arm III: Patients receive a higher dose of subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG microspheres with adjuvant GM-CSF. Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: A total of 15 patients (5 per treatment arm) will be accrued for this study.
- Conditions
- Breast Cancer, Lung Cancer, Ovarian Cancer
- Being tested
- HER-2/neu peptide vaccine, sargramostim
- Keywords
- stage IV breast cancer, stage IIIA breast cancer, stage III non-small cell lung cancer, stage IIIB breast 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 posted23 Apr 2004 (estimated)
- Study startMar 1999
- Primary completionJan 2001
- Study completionJan 2001
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
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary (Nora) Disis, University of Washington
- Investigators
- Mary (Nora) L. Disis, MD, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005023
- Sponsor's protocol ID
- CDR0000067339
- Other IDs
- UWASH-103, NCI-V99-1574
- Status last verified
- Nov 2017
- First submitted
- 6 Apr 2000
- Last updated
- 30 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Vaccine Trial of a HER-2/Neu Peptide Incorporated Into PLG Microspheres in Patients With Advanced Stage HER2-Expressing Cancers
- ClinicalTrials.gov ID
- NCT00005023
- Acronym / sponsor ID
- CDR0000067339
- Conditions
- Breast Cancer, Lung Cancer, Ovarian Cancer
- Keywords
- stage IV breast cancer, stage IIIA breast cancer, stage III non-small cell lung cancer, stage IIIB breast 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
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Mar 1999
- Primary completion
- Jan 2001 (actual)
- Study completion
- Jan 2001 (actual)
- First posted
- 23 Apr 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 may make the body build an immune response to tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have stage III or stage IV cancer.
Detailed description
OBJECTIVES: I. Determine the safety of serial intradermal or subcutaneous vaccinations of HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide (PLG) microspheres with adjuvant sargramostim (GM-CSF) in patients with stage III or IV HER-2 expressing cancers. II. Determine whether cytotoxic T lymphocytes (CTL) specific for the HER-2 protein can be elicited in patients with HLA-A2 by immunization with this regimen. III. Determine which route of immunization, intradermal or subcutaneous, is more effective in generating HER-2 specific CTL in these patients on this regimen. IV. Determine the extent to which escalated dose of PLG peptide affects the immune response in these patients on this regimen.
OUTLINE: Patients undergo leukapheresis prior to study and after final vaccination. Patients are sequentially entered into one of three treatment arms: Arm I: Patients receive an intradermal vaccination of HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide (PLG) microspheres with adjuvant sargramostim (GM-CSF). Arm II: Patients receive a subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG microspheres with adjuvant GM-CSF. Arm III: Patients receive a higher dose of subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG microspheres with adjuvant GM-CSF. Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: A total of 15 patients (5 per treatment arm) 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 |
|---|---|---|
| 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 30 Nov 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.
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 30 Nov 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.
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 30 Nov 2017.