in vitro-treated peripheral blood stem cell transplantation
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00006225
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NU 97B2
Secondary IDs
ID
Type
Description
Link
NU-97B2
NCI-V00-1611
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
Acronym
Not provided
Organization
Northwestern UniversityOTHER
Status Module
Record Verification Date
May 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 1999
Primary Completion Date
Jan 2004Actual
Completion Date
Jan 2004Actual
First Submitted Date
Sep 11, 2000
First Submission Date that Met QC Criteria
May 6, 2003
First Posted Date
May 7, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 18, 2011
Certification/Extension First Submitted that Passed QC Review
Feb 18, 2011
Certification/Extension First Posted Date
Feb 25, 2011Estimated
Last Update Submitted Date
May 31, 2012
Last Update Posted Date
Jun 6, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Northwestern UniversityOTHER
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Conditions Module
Conditions
Breast Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic/Myeloproliferative Diseases
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
filgrastim
Biological
recombinant flt3 ligand
Biological
recombinant human thrombopoietin
Biological
recombinant interleukin-3
Biological
in vitro-treated peripheral blood stem cell transplantation
Procedure
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
60 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Jane N. Winter, MD
Robert H. Lurie Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago
Illinois
60611
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
recurrent adult T-cell leukemia/lymphoma
primary central nervous system lymphoma
male breast cancer
intraocular lymphoma
stage I mantle cell lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II mantle cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult Burkitt lymphoma
contiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult lymphoblastic lymphoma