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Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia 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 Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia Clinical research trials and Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia 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 Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia. Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia 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 Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia clinical trial. Participants typically obtain the most effective healthcare available for their Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia 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 > "C" Clinical Trials Conditions > Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia  Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
For Condition: Philadelphia chromosome positive chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia,accelerated phase chronic myelogenous leukemia
Status: Suspended
Sponsor(s): University of Minnesota Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of chemotherapy and filgrastim followed by peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia.
Details: OBJECTIVES: I. Assess clinical outcomes, survival, and morbidity of transplantation therapy in patients with chronic myelogenous leukemia when treated with high dose chemotherapy and filgrastim (G-CSF) followed by autologous retrovirally transduced peripheral blood stem cell (PBSC) transplantation. II. Determine whether this priming treatment can increase the fraction of benign Philadelphia chromosome (Ph) negative hematopoietic progenitors in PBSC and reduce the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients. III. Assess whether retroviral transduction of mobilized PBSC progenitors determines the contribution of malignant Ph positive progenitors contaminating the graft to relapse after transplantation in these patients. IV. Determine whether this priming treatment can expand the benign progenitor population in the PBSC collections from these patients. PROTOCOL OUTLINE: In the priming phase, patients receive cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SQ) daily beginning on day 4 and continuing until the completion of leukapheresis. Peripheral blood stem cells (PBSC) are harvested 4-7 times between days 10 and 21 beginning when blood counts recover (CD34+ cells are selected from 2 of these PBSC collections and transduced with the LN NEO virus prior to cryopreservation). In the transplant phase, patients who have not received prior radiotherapy receive cyclophosphamide IV over 2 hours daily on days -7 and -6 and total body irradiation on days -4 through -1. Autologous PBSC and LN NEO transduced CD34+ cells are reinfused on day 0. Patients also receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover. Patients who have received prior radiotherapy receive oral busulfan every 6 hours on days -10 through -7 and cyclophosphamide IV daily on days -6 through -3. Autologous PBSC and LN NEO transduced CD34+ cells are reinfused on day 0. Patients also receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover. All patients then receive interferon alfa SQ daily until disease progression or unacceptable toxicity. Patients are followed at 3 weeks; at 3, 6, 9, 12, 18, and 24 months; and then annually thereafter. PROJECTED ACCRUAL: A total of 4-26 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia; Philadelphia chromosome positive OR BCR/ABL rearrangement - No blast crisis or post blast crisis - No moderate to severe fibrosis defined by bilateral trephine biopsies - Not eligible for or refused to participate in allogeneic marrow transplant protocols - No splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy --Prior/Concurrent Therapy-- - Biologic therapy: Prior interferon alfa allowed - Chemotherapy: Prior hydroxyurea allowed; At least 2 months since prior busulfan (at time of PBSC harvest) - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 18 to 65 - Performance status: Karnofsky 90-100% - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: Normal organ function (except bone marrow)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CatherineVerfaillie, Study Chair, University of Minnesota Cancer Center
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Additional Information:
Study ID Numbers: CDR0000067974; UMN-MT-9507
Study Start Date: June 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005986
Other Chronic Phase Chronic Myelogenous Leukemia Studies:
1. Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia
2. BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate
3. STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
4. Homoharringtonine in Treating Patients With Chronic Myelogenous Leukemia
5. Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
Related Studies:
Other chronic phase chronic myelogenous leukemia Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
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