search
Back to results

Biological Therapy in Treating Women With Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
cytokine therapy
sargramostim
carboplatin
cyclophosphamide
thiotepa
peripheral blood stem cell transplantation
Sponsored by
St. Luke's Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • St. Luke's Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 18, 2013
Sponsor
St. Luke's Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00002780
Brief Title
Biological Therapy in Treating Women With Metastatic Breast Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2001
Overall Recruitment Status
Unknown status
Study Start Date
May 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
St. Luke's Medical Center

4. Oversight

5. Study Description

Brief Summary
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 I/II trial to study the effectiveness of T cells and interleukin-2 combined with peripheral stem cell transplantation or bone marrow transplantation in treating women who have stage IIIB or metastatic breast cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
cytokine therapy
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
thiotepa
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P. Hanson, MD
Organizational Affiliation
St. Luke's Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Biological Therapy in Treating Women With Metastatic Breast Cancer

We'll reach out to this number within 24 hrs