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Biological Therapy in Treating Women With Metastatic Breast Cancer - Article


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Sargramostim Injection

GM-CSF; Leukine; Prokine



Clinical Trial: Biological Therapy in Treating Women With Metastatic Breast Cancer

This study is no longer recruiting patients.

Sponsored by: St. Luke's Medical Center
Information provided by: National Cancer Institute (NCI)

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 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.

Condition Treatment or Intervention Phase
stage IV breast cancer
recurrent breast cancer
stage IIIB breast cancer
 Drug: carboplatin
 Drug: cyclophosphamide
 Drug: interleukin-2
 Drug: interleukin-2/sargramostim
 Drug: sargramostim
 Drug: thiotepa
Phase I
Phase II

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of Infusion of Activated T Cells and Low Dose Interleukin-2 Combined With Autologous Peripheral Blood Stem Cell Transplantation in Women With Stage IIIB or Metastatic Adenocarcinoma of the Breast

Further Study Details: 

Study start: May 1996

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.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

--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

Location Information


Wisconsin
      St. Luke's Medical Center, Milwaukee,  Wisconsin,  53215,  United States

Study chairs or principal investigators

John P. Hanson, Jr.,  Study Chair,  St. Luke's Medical Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000064792; STLMC-BRM-9503; NCI-V96-0902
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002780
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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November 18, 2008



Page Updated: June 1, 2005
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