Know Cancer

or
forgot password

Phase II Trial of the HER2/Neu Peptide GP2 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2+ OR the Modified HER2/Neu Peptide AE37 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

Phase II Trial of the HER2/Neu Peptide GP2 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2+ OR the Modified HER2/Neu Peptide AE37 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients


OBJECTIVES:

- To determine if the GP2 peptide/GM-CSF vaccine reduces the recurrence rate in
HLA-A2-positive, HER2/neu-positive, node-positive, or high-risk node-negative breast
cancer patients randomized to receive the vaccine versus the immunoadjuvant,
sargramostim (GM-CSF), alone.

- To determine if the AE37 peptide/GM-CSF vaccine reduces the recurrence rate in
HLA-A2-negative, HER2/neu-positive, node-positive or high-risk node-negative breast
cancer patients randomized to receive the vaccine versus the immunoadjuvant, GM-CSF,
alone.

- To monitor the invitro and invivo immunologic responses to the vaccines and correlate
these responses with the clinical outcomes.

- To monitor for any unexpected toxicities with the vaccines.

OUTLINE: This is a multicenter study. Patients are stratified according to nodal status.
Patients are randomized to 1 of 4 treatment arms.

- Arm I: HLA-A2-positive patients receive GP2 peptide/GM-CSF vaccine intradermally (ID)
every 3-4 weeks for a total of up to 6 inoculations.

- Arm II: HLA-A2-positive patients receive solely GM-CSF ID

- Arm III: HLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4
weeks for a total of up to 6 inoculations.

- Arm IV: HLA-A2-negative patients receive solely GM-CSF ID

After completion of study therapy, patients are followed every 3 months for the first 24
months and then every 6 months for an additional 36 months.

Booster inoculations are administered at 12, 18, 24, and 30 months from the date of
patients' enrollment into the study. One booster inoculation is administered at each
timepoint (+/- 2 weeks) and will be the same inoculation (vaccine or GM-CSF only) as what
patients received during their regular inoculation series.

Inclusion Criteria


DISEASE CHARACTERISTICS:

Inclusion criteria:

1. Lymph node-positive breast cancer or high-risk lymph node-negative breast cancer.
The latter is defined by any one of the following criteria:

- T2 disease

- Grade 3 disease

- Lymphovascular invasion

- Estrogen receptor- or progesterone receptor-negative disease

- HER2/neu-expressing tumor (immunohistochemistry [IHC] 3+ and/or amplified
fluorescence in situ hybridization [FISH] >2.2, or N0 (i+))

2. HER2/neu-expressing tumor (IHC 1-3+ and or positive FISH >1.2)

3. Completion of primary standard of care breast cancer therapies (i.e., surgery,
chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care
for patients' specific cancer)

4. Clinically cancer-free (no evidence of disease)

5. Patients may be enrolled between 1-6 months from completion of standard primary
breast cancer therapies

6. Good performance status (as defined in Exclusion Criteria)

7. Capable of informed consent

Exclusion criteria:

1. HER2/neu-negative breast cancers (IHC 0)

2. Clinical and/or radiographic evidence of residual or persistent breast cancer

3. Receiving immunosuppressive therapy to include chemotherapy, steroids, or
methotrexate

4. In poor health (Karnofsky <60%, ECOG >/-2)

5. Total bilirubin >1.8, creatinine >2, hemoglobin <10, platelets <50,000, WBC <2,000)

6. Active interstitial lung disease; asthma requiring more than as needed
bronchodilators for management; or other autoimmune lung disease

7. Pregnancy (urine hCG)

8. Breast feeding

9. History of autoimmune disease

10. Involved in other experimental protocols (except with permission of the other study
PI)

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Female or male

- Menopausal status not specified

- Immunologically intact by recall anergy testing

- Negative pregnancy test

Exclusion criteria:

- Karnofsky 0-60% or ECOG ≥ 2

- Total bilirubin > 1.8 g/dL

- Creatinine > 2.0 g/dL

- Hemoglobin < 10.0 g/dL

- Platelet count < 50,000/mm³

- WBC< 2,000/mm³

- Active pulmonary disease requiring medication that includes multiple inhalers

- Pregnancy

- Breastfeeding

- History of autoimmune disease

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

- See Disease Characteristics

Exclusion criteria:

- Concurrent immunosuppressive therapy including chemotherapy, steroids, or
methotrexate

- Concurrent participation in another experimental treatment (except with permission of
the other study investigator)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Disease recurrence

Outcome Description:

The following will be compared: disease recurrence rates between HLA-A2-negative patients receiving the AE37 + GM-CSF vaccine and HLA-A2-negative patients receiving GM-CSF alone disease recurrence rates between HLA-A2-positive patients receiving the GP2 + GM-CSF vaccine and HLA-A2-positive patients receiving GM-CSF alone disease recurrence rates between all four arms of the trial.

Outcome Time Frame:

Five years (from date of enrollment to the study through the end of the follow-up period)

Safety Issue:

No

Principal Investigator

Elizabeth A Mittendorf, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000562261

NCT ID:

NCT00524277

Start Date:

January 2007

Completion Date:

November 2014

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • male breast cancer
  • Breast Neoplasms

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Sibley Memorial HospitalWashington, District of Columbia  20016
Madigan Army Medical Center - TacomaTacoma, Washington  98431
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
University of Hawaii Cancer CenterHonolulu, Hawaii  96813
Walter Reed National Military Medical CenterBethesda, Maryland  20889
Carl R. Darnall Army Medical CenterFort Hood, Texas  76544-4752
San Antonio Army Medical CenterFort Sam Houston, Texas  78234-6200
STOH Clinical ResearchSan Antonio, Texas  78229
MedStar Union Memorial HospitalBaltimore, Maryland  21218
MedStar Good Samaritan Hospital Cancer CenterBaltimore, Maryland  21239