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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.
Study NCT00006225.   Last updated on November 16, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
Official Title  Ex Vivo Expanded Megakaryocytes for Supportive Care of Breast Cancer Patients: A Phase I/II Study
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.

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 Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Active Control
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Breast Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic/Myeloproliferative Diseases
Intervention  Drug: filgrastim
Drug: recombinant flt3 ligand
Drug: recombinant human thrombopoietin
Drug: recombinant interleukin-3
Procedure: in vitro-treated peripheral blood stem cell transplantation
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  November 1999
Completion Date
Eligibility 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
Gender Both
Ages 18 Years to 60 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00006225
Organization ID CDR0000068145
Secondary IDs †† NU-97B2, NCI-V00-1611
Study Sponsor  Robert H. Lurie Cancer Center
Collaborators ††
Investigators 
Study Chair:     Jane N. Winter, MD     Robert H. Lurie Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date October 2003
First Received Date  September 11, 2000
Last Updated Date November 16, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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