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Stem Cell Transplantation in Treating Patients with Hematologic Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Stem Cell Transplantation in Treating Patients with Hematologic Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Stem Cell Transplantation in Treating Patients with Hematologic Cancer Clinical research trials and Stem Cell Transplantation in Treating Patients with Hematologic Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Stem Cell Transplantation in Treating Patients with Hematologic Cancer. Stem Cell Transplantation in Treating Patients with Hematologic Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Stem Cell Transplantation in Treating Patients with Hematologic Cancer clinical trial. Human subjects often get the best healthcare possible for their Stem Cell Transplantation in Treating Patients with Hematologic Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Stem Cell Transplantation in Treating Patients with Hematologic Cancer  Stem Cell Transplantation in Treating Patients with Hematologic Cancer
Stem Cell Transplantation in Treating Patients with Hematologic Cancer
For Condition: Multiple Myeloma,Eye Cancer,Lymphoma,Leukemia
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Robert H. Lurie Cancer Center
Synopsis: RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of treated donor stem cell transplantation in treating patients who have hematologic cancer.
Details: OBJECTIVES: I. Determine if megadose CD34 cells and intense immunosuppression administered before and after partially matched related donor (PMRD) hematopoietic stem cell (HSC) transplantation results in engraftment in patients with high risk hematologic malignancies. II. Determine the incidence and severity of acute grade (I-IV) and chronic (limited or extensive) graft versus host disease in patients after rigorous T-cell depletion in PMRD HSC transplantation. PROTOCOL OUTLINE: Harvest: Bone marrow and peripheral blood stem cells (PBSC) are harvested from a related 1, 2, or 3 HLA antigen mismatched donor. PBSC are selected for CD34+ cells and T-cells are depleted. Conditioning: Patients undergo total body irradiation twice daily on days -10 to -7 and once on day -6. Patients receive cladribine IV continuously on days -10 to -6; etoposide IV over 2 hours on day -5; and cyclophosphamide IV over 2 hours, antithymocyte globulin (ATG) IV over 10-12 hours, and methylprednisolone IV over 1 hour on days -4 to -2. Transplantation: T-cell depleted PBSC and bone marrow are infused on day 0. Patients receive G-CSF SQ daily beginning on day 0 and continuing until blood counts recover. Graft versus host disease prophylaxis: Patients receive tacrolimus IV every 12 hours beginning on day -2 and continuing orally 4 times a day for 6-12 months at the discretion of the protocol investigator. Patients receive ATG IV over 10-12 hours and methylprednisolone IV over 1 hour on days 5-15 followed by a taper of methylprednisolone. Patients are followed every week through day 100 and then at 6 and 12 months. PROJECTED ACCRUAL: A total of 12-20 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /45 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven hematologic malignancy with relapse after allogeneic bone marrow transplantation (BMT) or autologous BMT if no HLA matched sibling donor is available OR Histologically proven acute myeloid leukemia (AML) without an available HLA matched sibling donor and with one of the following: Failure of induction, defined as inability to obtain remission with 2 courses of induction or failure during treatment; Second or greater remission OR Histologically proven acute lymphocytic leukemia (ALL) in an adult over age 15 without an available HLA matched sibling donor and with one of the following: Philadelphia chromosome positivity by cytogenetics or PCR; Relapse or second or greater remission; Two or more prognostic features (over age 30, WBC on presentation over 35,000/mm3, time to complete response over 4 weeks, t(4:11), or B-cell ALL) OR Histologically proven chronic myelogenous leukemia; In chronic phase without an A, B, and DR unrelated matched donor OR In accelerated phase, defined as new cytogenetic abnormalities or difficulty maintaining a normal WBC due to dose limiting cytopenias (thrombocytopenias or anemia) from hydroxyurea or interferon OR In blast transformation OR Histologically proven aplastic anemia without an available HLA matched sibling donor and failure of an immunosuppressive therapy regimen using either cyclosporine, antithymocyte globulin, or both OR Histologically proven lymphoma without an available HLA matched donor and failure of at least 2 different chemotherapy regimens OR Histologically proven cutaneous T-cell lymphoma without an available HLA matched donor and failure of interferon and PUVA (psoralen and ultraviolet A radiation) OR Histologically proven myelodysplastic syndrome without an available HLA matched sibling donor and with one of the following: 5% or greater blasts in marrow; Multiple cytogenetic abnormalities; History of infections from neutropenia - 1, 2, or 3 antigen mismatched related donor available --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: Physiologic age 45 and under - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics - Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT and SGPT no greater than 2 times upper limit of normal - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No myocardial infarction within the past 6 months; No coronary artery disease requiring medical therapy; Resting LVEF at least 40% - Pulmonary: FEV1/FVC at least 60% predicted; DLCO at least 60% predicted - Other: HIV negative; No prior malignancy except basal cell or squamous cell skin cancer; Other malignancies for which the patient is cured by local surgical therapy, such as head and neck cancer or stage I breast cancer, are considered on an individual basis; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception; No psychiatric illness or mental deficiency that would preclude compliance or informed consent
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardBurt, Study Chair, Robert H. Lurie Cancer Center
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Additional Information:
Study ID Numbers: CDR0000067583; NU-97H1,NCI-G00-1691
Study Start Date: October 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004904
Other Eye Cancer Studies:
1. Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer
2. Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
3. Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
4. VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
5. Chemotherapy Plus Donor White Blood Cell Infusion in Treating Patients With Relapsed Hematologic Cancer Following Donor Peripheral Stem Cell Transplantation
Related Studies:
Other Eye Cancer Clinical Trials
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Other Chicago Clinical Trials
Stem Cell Transplantation in Treating Patients with Hematologic Cancer
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