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Immunotherapy for Breast Carcinoma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

Immunotherapy for Breast Carcinoma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy


OBJECTIVES:

- Determine the efficacy of immunotherapy with irradiated autologous tumor cell vaccine
and sargramostim (GM-CSF) followed by monoclonal antibody OKT3- activated T lymphocytes
and interleukin-2 in combination with standard therapy in terms of response rate in
patients with stage III or IV breast cancer.

- Determine the immunogenicity of breast cancer in this patient population.

OUTLINE: Patients are stratified according to extent of disease at the time of
immunotherapy, extent of antigen specific response to vaccination, performance status (0 vs
1), prior therapy (yes vs no), and gender.

Patients undergo surgical debulking of tumor on week 1 followed by adjuvant chemotherapy.
Within 2-4 weeks of chemotherapy, patients are vaccinated with irradiated autologous tumor
cells and sargramostim (GM-CSF), then receive GM-CSF alone intradermally at vaccination
sites daily for 4 days. Patients are revaccinated 2 weeks later.

Patients undergo peripheral blood mononuclear cell collection two weeks after the second
vaccination. Peripheral blood mononuclear cells are stimulated with anti-CD3 monoclonal
antibody (OKT3) and interleukin-2, producing activated T lymphocytes. The activated T
lymphocytes are infused IV over 1-6 hours followed by 5 doses of interleukin-2 IV every
other day over 10 days. Treatment continues in the absence of disease progression or
unacceptable toxicity.

Patients may receive one additional course of immunotherapy as above.

Patients are followed every 3 months for 2 years, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven stage III or IV breast carcinoma

- Resectable disease

- At least 50,000,000 viable cells obtained from surgical specimen for use in
the immunization part of this study

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Menopausal status:

- Not specified

Performance status:

- SWOG 0 or 1

Life expectancy:

- At least 6 months

Hematopoietic:

- Granulocyte count at least 1,500/mm^3

- Platelet count at least lower limit of normal

- No active or recent uncontrolled bleeding

Hepatic:

- Bilirubin normal

- SGOT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN
if liver metastases present)

Renal:

- Creatinine normal

Other:

- Negative stool guaiac

- No impaired immunity

- No uncontrolled diabetes

- No active uncontrolled infections

- No other serious disease

- No other malignancy within the past 5 years except curatively treated basal or
squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics

Other:

- At least 2 weeks since prior therapy and recovered

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Roy D. Baynes, MD, PhD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067236

NCT ID:

NCT00004018

Start Date:

June 1997

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201