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

NCT ID: NCT00006225

Last Updated: 2012-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30
• Study Completion Date: 2004-01-31

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

Breast Cancer; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic/Myeloproliferative Diseases

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

filgrastim

Intervention Type: BIOLOGICAL

recombinant flt3 ligand

Intervention Type: BIOLOGICAL

recombinant human thrombopoietin

Intervention Type: BIOLOGICAL

recombinant interleukin-3

Intervention Type: BIOLOGICAL

in vitro-treated peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jane N. Winter, MD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Locations

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NU-97B2

Identifier Type: -

Identifier Source: secondary_id

NCI-V00-1611

Identifier Type: -

Identifier Source: secondary_id

NU 97B2

Identifier Type: -

Identifier Source: org_study_id