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Biological Therapy Following Surgery and Chemotherapy in Treating Patients With Stage III or Stage IV Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004018
First received: November 1, 1999
Last updated: April 13, 2010
Last verified: March 2005
History of Changes
  Purpose

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery and chemotherapy in treating patients who have stage III or stage IV breast cancer.


Condition Intervention Phase
Breast Cancer
 Biological: aldesleukin
Biological: autologous tumor cell vaccine
Biological: muromonab-CD3
Biological: sargramostim
Biological: therapeutic autologous lymphocytes
Drug: chemotherapy
Procedure: surgical procedure
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Immunotherapy for Breast Carcinoma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 60
Study Start Date: June 1997
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004018

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Roy D. Baynes, MD, PhD, FACP Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00004018     History of Changes
Other Study ID Numbers: CDR0000067236, WSU-C-1403-BR, NCI-G99-1561
Study First Received: November 1, 1999
Last Updated: April 13, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Muromonab-CD3
Aldesleukin
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Immunosuppressive Agents
Antineoplastic Agents
Therapeutic Uses
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 19, 2013