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A Study of hTERT/Survivin Multi-Peptide Vaccination With Basiliximab And Prevnar For Patients With Metastatic Breast Cancer


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

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Trial Information

A Study of hTERT/Survivin Multi-Peptide Vaccination With Basiliximab And Prevnar For Patients With Metastatic Breast Cancer


hTERT is widely found in breast cancer cells and has a role in tumor growth and development,
making it attractive for immunotherapy. Also, recent data suggest that breast cancer is
potentially responsive to immunological therapies. In one trial, patients with advanced
cancer received a series of hTERT vaccinations and 4 of 7 patients with advanced breast or
prostate carcinoma developed hTERT-specific T lymphocytes. Partial tumor regression was
observed in 1 patient. In a second trial, 19 HLA A2+ patients with metastatic breast cancer
were vaccinated with hTERT 1540 peptide in adjuvant with GM-CSF. 68% of patients exhibited
immunological responses with development of CD8+ hTERT-specific T-cells. Overall survival
of vaccine responders was signifiantly better than the overall survival on non-responders.
In order to expand the number of possible immune responses and to potentially bypass immune
tolerance, multiple peptides have been added to the vaccine. In addition, the monoclonal
antibody basiliximab is included to decrease the regulatory T cells which prevent the immune
system to work against the tumor, and GM-CSF and Prevnar are used to boost the immune
system. Subjects will receive a maximum of 28 vaccinations over a 24 months period.


Inclusion Criteria:



- Stage IV (AJCC) breast cancer patients who have failed at least one conventional
therapy for metastatic disease.

- HLA-A2 blood positive

- Evidence of measurable or evaluable disease by clinical, radiographic, or laboratory
assessment.

- Age greater than 18 years old

- Baseline Eastern Cooperative Oncology Group (ECOG) Clinical Performance Status 0 or 1

- Life expectancy greater than 6 months

- Adequate hematologic function established within 14 days before treatment: WBC equal
to or greater than 3.0, Plt equal to or greater than 75,000, Hgb equal to or greater
than 10 g/dl

- Adequate renal function established within 14 days before treatment defined as serum
creatinine less than 1.5 times upper limit of normal

- Adequate hepatic function established within 14 days before treatment defined as:
Total bilirubin, less than 1.5 times upper limit of normal, and ALT and AST less than
2.5 times upper limit of normal

- Contrast CT and/or MRI of the brain negative for central nervous system metastases
within 30 days of treatment

- Women of child bearing potential must have a negative pregnancy test (blood or urine)
within 14 days before treatment and agree to use appropriate contraception from study
screen through the duration of the trial. Men must agree to use appropriate
contraception from study screen through the duration of the trial.

- Signed and dated written informed consent

Exclusion Criteria:

- History of brain metastases within the last four years

- Positivity for HIV-1/HIV-2, Hepatitis B virus, and Hepatitis C virus active infection

- The use of the following within 14 days before treatment: Chemotherapy, Radiation
therapy, Immunosuppressive drugs, Systemic glucocorticoids, Hematopoietic growth
factors, Experimental therapy

- Use of anti-coagulants such as coumadin, heparin, or Lovenox within 14 days before
treatment, with the exception of low dose anti-coagulants to maintain intravenous
catheter patency.

- Initiation of hormonal agent (such as tamoxifen, anastrazole, or letrozole) in the 30
days before treatment. 6. Patients who have been on a hormonal agent for at least 30
days prior to treatment with progressive or stable disease are permitted to enroll,
but required to stay on this hormonal agent for the duration of the study.

- Initiation of immunotherapy (such as trastuzumab-Herceptin) in the 30 days before
treatment. Patients who have been on trastuzumab for at least 30 days prior to
treatment with progressive or stable disease are permitted to enroll, but required to
stay on trastuzumab for the duration of the study.

- History of bone marrow or stem cell transplantation (allogeneic or autologous)

- Pregnant women or nursing mothers

- History of alcohol abuse or illicit drug use within 12 months of study initiation

- Clinically significant comorbid disease or other underlying condition, including
major autoimmune disorders that would contraindicate study therapy or confuse
interpretation of study results

- Significant psychiatric disorder and any other reason in the Investigators opinion
that would jeopardize protocol compliance or compromise the patients ability to give
informed consent.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Number of Adverse Events

Safety Issue:

Yes

Principal Investigator

Kevin Fox, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

UPCC 03111

NCT ID:

NCT01660529

Start Date:

June 2012

Completion Date:

June 2018

Related Keywords:

  • Metastatic Breast Cancer
  • Subjects with metastatic breast cancer who have failed at least one standard
  • of care regimen
  • Breast Neoplasms

Name

Location

Abramson Cancer Center, University of PennsylvaniaPhiladelphia, Pennsylvania  19104