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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006225
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
Northwestern University

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic/Myeloproliferative Diseases Biological: filgrastim Biological: recombinant flt3 ligand Biological: recombinant human thrombopoietin Biological: recombinant interleukin-3 Procedure: in vitro-treated peripheral blood stem cell transplantation Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Ex Vivo Expanded Megakaryocytes for Supportive Care of Breast Cancer Patients: A Phase I/II Study
Study Start Date : November 1999
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Lymphosarcoma Follicular Lymphoma Chronic Lymphocytic Leukemia Multiple Myeloma Mantle Cell Lymphoma Chronic Myeloproliferative Disorders B-cell Lymphoma Cutaneous T-cell Lymphoma Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Diffuse Large B-Cell Lymphoma Leukemia, T-cell, Chronic Adult T-cell Leukemia/lymphoma Waldenstrom Macroglobulinemia Mycosis Fungoides Primary Central Nervous System Lymphoma Hodgkin Lymphoma Marginal Zone Lymphoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Sezary Syndrome Plasmacytoma Myelodysplastic/myeloproliferative Disease Burkitt Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Breast Cancer, Male Aggressive NK Cell Leukemia T-cell Large Granular Lymphocyte Leukemia

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006225


Locations
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United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Study Chair: Jane N. Winter, MD Robert H. Lurie Cancer Center
More Information
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Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00006225    
Other Study ID Numbers: NU 97B2
NU-97B2
NCI-V00-1611
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: May 2012
Keywords provided by Northwestern University:
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 multiple myeloma
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
Additional relevant MeSH terms:
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Lymphoma
Breast Neoplasms
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Breast Diseases
 Skin Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Flt3 ligand protein
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents