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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00006225
First received: September 11, 2000
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  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
 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

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Study Start Date: November 1999
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
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
Northwestern University
Investigators
Study Chair: Jane N. Winter, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00006225     History of Changes
Other Study ID Numbers: NU 97B2, NU-97B2, NCI-V00-1611
Study First Received: September 11, 2000
Last Updated: May 31, 2012
Health Authority: United States: Federal Government

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:
Breast Neoplasms
Neoplasms
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myeloproliferative Disorders
Lymphoma, Large-Cell, Immunoblastic
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Lenograstim
Flt3 ligand protein
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on June 18, 2013