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INFUSION OF ACTIVATED T CELLS AND LOW DOSE INTERLEUKIN 2 COMBINED WITH PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR THE TREATMENT OF WOMEN WITH METASTATIC BREAST CANCER: PHASE I/II


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

INFUSION OF ACTIVATED T CELLS AND LOW DOSE INTERLEUKIN 2 COMBINED WITH PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR THE TREATMENT OF WOMEN WITH METASTATIC BREAST CANCER: PHASE I/II


OBJECTIVES: I. Evaluate the toxicities of the combination of low dose interleukin-2 (IL-2)
sargramostim (GM-CSF), and multiple doses of activated T cells (ATC) following peripheral
blood stem cell transplantation in women with stage IIIB or metastatic adenocarcinoma of the
breast. II. Evaluate the efficacy of this regimen in these patients.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously daily for 5 days prior to
peripheral blood stem cell (PBSC) collection or for 2 days prior to bone marrow harvest.
Following PBSC collection or bone marrow harvest, patients receive high dose chemotherapy
consisting of cyclophosphamide IV, carboplatin IV, and thiotepa IV over days -6 through -3.
Patients undergo PBSC transplantation on day 0. Following PBSC transplantation, patients
receive multiple doses of monoclonal antibody OKT3 activated T lymphocytes IV over 1 hour
between days 1 and 65, continuous low dose interleukin-2 (IL-2) IV over days 1-65, and
sargramostim (GM-CSF) subcutaneously on days 5-21. Patients are followed at day 100, as
clinically indicated, and then annually.

PROJECTED ACCRUAL: Approximately 40-60 patients will be accrued for this study within 1-2
years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically documented metastatic adenocarcinoma of the breast
Concurrent intraductal or lobular carcinoma in situ allowed Bilateral disease allowed
Measurable or evaluable recurrent metastatic disease (Stage IIIB or IV) documented by
radiograph, CT scan, nuclear medicine scan, or physical exam Tumor must be clinically
chemosensitive as documented by a reduction in tumor burden No clinical evidence of brain
metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet
count at least 50,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin less than 1.5
times normal Hepatitis B surface antigen negative Renal: Creatinine less than 1.8 mg/dL
Creatinine clearance normal Blood urea nitrogen (BUN) less than 1.5 times normal
Cardiovascular: Ejection fraction at least 45% by MUGA No uncontrolled or significant
cardiovascular disease including myocardial infarction (less than 1 year) or congestive
heart failure Pulmonary: PFT-FEV1 at least 60% of predicted DLCO and FVC at least 60% of
predicted Other: Not pregnant Negative pregnancy test HIV negative No serious medical or
psychiatric illness No prior or concurrent malignancy, other than curatively treated
carcinoma in situ of the cervix or basal cell skin cancer

PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent hormonal therapy for
breast cancer

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

John P. Hanson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Luke's Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000064792

NCT ID:

NCT00002780

Start Date:

May 1996

Completion Date:

Related Keywords:

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

Name

Location

St. Luke's Medical CenterMilwaukee, Wisconsin  53215