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Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer Clinical research trials and Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer. Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer  Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
For Condition: Breast Cancer,Male Breast Cancer,myelodysplastic and myeloproliferative diseases,Leukemia,plasma cell neoplasm,Lymphoma
Status: No longer recruiting
Sponsor(s): Robert H. Lurie Cancer Center ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JaneWinter, Study Chair, Robert H. Lurie Cancer Center
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: CDR0000068145; NCI-V00-1611,NU-97B2
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006225
Other Lymphoma Studies:
1. High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
2. BCX-1777 in Treating Patients With Refractory Hematologic Cancer
3. Combining Chemotherapy, Tacrolimus, Mycophenolate Mofetil, and Radiation Therapy with Donor Bone Marrow Transplantation in Treating Patients with Hematologic Cancer
4. Donor Umbilical Cord Blood Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
5. Donor Stem Cell Transplantation in Treating Patients With Hematologic Cancer
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Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
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