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Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: Robert H. Lurie Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006225
  Purpose

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy.

PURPOSE: Randomized phase I/II trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have breast cancer or hematologic cancer.


Condition Intervention Phase
Breast Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic/Myeloproliferative Diseases
Drug: filgrastim
Drug: recombinant flt3 ligand
Drug: recombinant human thrombopoietin
Drug: recombinant interleukin-3
Procedure: in vitro-treated peripheral blood stem cell transplantation
Phase I
Phase II

Genetics Home Reference related topics:   aceruloplasminemia    breast cancer    hemophilia   

MedlinePlus related topics:   Breast Cancer    Cancer    Fungal Infections    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lymphoma    Multiple Myeloma   

ChemIDplus related topics:   Filgrastim   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
Official Title:   Ex Vivo Expanded Megakaryocytes for Supportive Care of Breast Cancer Patients: A Phase I/II Study

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

Study Start Date:   November 1999

Detailed Description:

OBJECTIVES:

  • Determine the toxicity of ex vivo expanded megakaryocytes (EVE MK) as a supplement to peripheral blood stem cell (PBSC) transplantation in patients with breast cancer or hematologic malignancies.
  • Compare the effect of this treatment regimen on platelet recovery and platelet function in these patients vs historical controls.
  • Compare the frequency of malignant cells in the EVE MK vs the uncultured PBSC collection in these patients.
  • Determine the optimal time of MK harvest for the production of platelets in vivo.
  • Determine the required number of MKs for clinical efficacy in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 durations of CD34+ culture times (6 days vs 9 days).

After an initial harvest of filgrastim (G-CSF)-mobilized autologous peripheral blood stem cells (PBSC) for transplantation, patients receive one additional dose of G-CSF and undergo one additional apheresis. The CD34+ cells are cultured in the presence of recombinant human thrombopoietin, interleukin-3, and flt3 ligand to expand megakaryocytes. Patients then undergo treatment with high-dose chemotherapy (and, in some cases, total body irradiation) followed by reinfusion of the conventional PBSC harvest and the ex vivo expanded megakaryocytes.

Patients are followed until blood counts recover.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of carcinoma of the breast or hematologic malignancies
  • No metastases to bone marrow
  • Planned high-dose chemotherapy with autologous peripheral blood stem cell transplantation
  • At least 2.0 million CD34+ cells/kg collected
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 to 60

Sex:

  • Female or male

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • SGOT or SGPT less than 2.5 times upper limit of normal (ULN)
  • Bilirubin less than 2.5 times ULN (except in Gilbert's syndrome)
  • Alkaline phosphatase less than 2.5 times ULN
  • No active hepatitis B or C

Renal:

  • Creatinine clearance greater than 50 mL/min

Cardiovascular:

  • Normal ejection fraction

Pulmonary:

  • DLCO at least 50% predicted
  • FEV_1 and/or FVC at least 75% predicted

Other:

  • No concurrent serious nonneoplastic disease that would preclude study entry
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006225

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University    
      Chicago, Illinois, United States, 60611

Sponsors and Collaborators
Robert H. Lurie Cancer Center

Investigators
Study Chair:     Jane N. Winter, MD     Robert H. Lurie Cancer Center    
  More Information

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

Study ID Numbers:   CDR0000068145, NU-97B2, NCI-V00-1611
First Received:   September 11, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006225
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV adult Hodgkin lymphoma  
stage IV breast cancer  
stage IIIA breast cancer  
recurrent breast cancer  
stage IIIB breast cancer  
stage IIIC breast cancer  
recurrent adult Hodgkin lymphoma  
stage II cutaneous T-cell non-Hodgkin lymphoma  
stage III cutaneous T-cell non-Hodgkin lymphoma  
stage IV cutaneous T-cell non-Hodgkin lymphoma  
recurrent cutaneous T-cell non-Hodgkin lymphoma  
isolated plasmacytoma of bone  
extramedullary plasmacytoma  
refractory plasma cell neoplasm  
Waldenstrom macroglobulinemia  
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage II chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
T-cell large granular lymphocyte leukemia
acute undifferentiated leukemia
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma

Study placed in the following topic categories:
Sezary syndrome
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Mycoses
Hemorrhagic Disorders
Multiple myeloma
Lymphoma, Large-Cell, Anaplastic
Acute myeloid leukemia, adult
Hodgkin Disease
Breast Diseases
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, B-cell, chronic
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Blood Coagulation Disorders
Acute myelogenous leukemia
Myeloproliferative Disorders
Breast Neoplasms
Leukemia, Myeloid
Multiple Myeloma
Waldenstrom Macroglobulinemia

Additional relevant MeSH terms:
Radiation-Protective Agents
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Immunologic Factors
Immune System Diseases
Blood Protein Disorders
Physiological Effects of Drugs
Adjuvants, Immunologic
Cardiovascular Diseases
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008




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