Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
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Compare the effect of this treatment regimen on platelet recovery and platelet function in these patients vs historical controls.
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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.
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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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of carcinoma of the breast or hematologic malignancies
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No metastases to bone marrow
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Planned high-dose chemotherapy with autologous peripheral blood stem cell transplantation
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
Investigators
- Study Chair: Jane N. Winter, MD, Robert H. Lurie Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NU 97B2
- NU-97B2
- NCI-V00-1611