Factor VIIa, Recombinant |
NovoSeven |
Clinical Trial: Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
This study is no longer recruiting patients.
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 | Treatment or Intervention | Phase |
|---|---|---|
| Breast Cancer Leukemia Lymphoma Male Breast Cancer myelodysplastic and myeloproliferative diseases plasma cell neoplasm | Drug: filgrastim Drug: flt3 ligand Drug: interleukin-3 Drug: recombinant human thrombopoietin Procedure: biological response modifier therapy Procedure: bone marrow ablation with stem cell support Procedure: colony-stimulating factor therapy Procedure: cytokine therapy Procedure: in vitro-treated peripheral blood stem cell transplantation Procedure: interleukin therapy | Phase I Phase II |
MedlinePlus related topics: Blood and Blood Disorders; Breast Cancer; Cancer; Cancer Alternative Therapy; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma; Male Breast Cancer; Multiple Myeloma
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Randomized Study of Ex Vivo Expanded Megakaryocytes in Patients With Breast Cancer or Hematologic Malignancies
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 - 60 Years, Genders Eligible for Study: Both
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/mm3; Platelet count greater than 100,000/mm3
- 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
Location Information
Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, 60611, United States
Jane N. Winter, MD, Study Chair, Robert H. Lurie Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: February 2004
Last Updated: October 13, 2004
Record first received: September 11, 2000
ClinicalTrials.gov Identifier: NCT00006225
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Factor VIIa, Recombinant (Drug Digest)
- NovoSeven (Drug Digest)

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