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

Breast Cancer Clinical Trial

Official title:

Ex Vivo Expanded Megakaryocytes for Supportive Care of Breast Cancer Patients: A Phase I/II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006225
• Other study ID #: NU 97B2
• Secondary ID: NU-97B2NCI-V00-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 11, 2000
• Last updated: May 31, 2012
• Start date: November 1999
• Est. completion date: January 2004

Study information

• Verified date: May 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Diseases
• Myeloproliferative Disorders
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Biological:
• filgrastim

• recombinant flt3 ligand

• recombinant human thrombopoietin

• recombinant interleukin-3

Procedure:
• in vitro-treated peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States,