Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer - Full Text View

Sponsor:	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	Biological: filgrastim Biological: recombinant flt3 ligand Biological: recombinant human thrombopoietin Biological: recombinant interleukin-3 Procedure: in vitro-treated peripheral blood stem cell transplantation	Phase I Phase II

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

Resource links provided by NLM:

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

Drug Information available for: Filgrastim

U.S. FDA Resources

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000068145, NU-97B2, NCI-V00-1611
Study First Received:	September 11, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00006225 History of Changes
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 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:

Flt3 ligand protein
Radiation-Protective Agents
Immunologic Factors
Blood Protein Disorders
Physiological Effects of Drugs
Paraproteinemias
Hemostatic Disorders
Leukemia
Neoplasms by Site
Hemorrhagic Disorders
Lymphoma, Large-Cell, Immunoblastic
Cardiovascular Diseases
Lymphoma
Breast Diseases
Neoplasms by Histologic Type

Immunoproliferative Disorders
Skin Diseases
Immune System Diseases
Hematologic Diseases
Adjuvants, Immunologic
Myeloproliferative Disorders
Vascular Diseases
Breast Neoplasms
Protective Agents
Pharmacologic Actions
Multiple Myeloma
Lymphatic Diseases
Neoplasms
Bone Marrow Diseases
Myelodysplastic-Myeloproliferative Diseases

ClinicalTrials.gov processed this record on November 27, 2009