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Donor Stem Cell Transplantation in Treating Patients With 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 Donor Stem Cell Transplantation in Treating Patients With Hematologic Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Donor Stem Cell Transplantation in Treating Patients With Hematologic Cancer Clinical research trials and Donor Stem Cell Transplantation in Treating Patients With 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 Donor Stem Cell Transplantation in Treating Patients With Hematologic Cancer. Donor Stem Cell Transplantation in Treating Patients With 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 Donor Stem Cell Transplantation in Treating Patients With Hematologic Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Donor Stem Cell Transplantation in Treating Patients With 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 > "D" Clinical Trials Conditions > Donor Stem Cell Transplantation in Treating Patients With Hematologic Cancer  Donor Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Donor Stem Cell Transplantation in Treating Patients With Hematologic Cancer
For Condition: childhood non-Hodgkin's lymphoma,myelodysplastic and myeloproliferative diseases,Leukemia,Lymphoma
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy with donor stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation to kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy with or without radiation therapy followed by donor stem cell transplantation in treating patients who have hematologic cancer.
Details: OBJECTIVES: - Determine a standard approach to hematopoietic stem cell transplantation with matched unrelated donors in patients with hematologic malignancies. - Determine the toxicity of this regimen in these patients. - Determine the relapse rate and survival rate in patients treated with this regimen. - Correlate incidence and severity of graft-versus-host disease with relapse and survival in patients treated with this regimen. OUTLINE: Patients receive 1 of the following preparative regimens: - Regimen A: Patients receive cytarabine IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1. - Regimen B: Patients receive cyclophosphamide IV and TBI as in regimen A. - Regimen B2: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1. - Regimen C: Patients receive oral busulfan 4 times daily on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 to -2. All patients undergo stem cell transplantation from a matched, unrelated donor on day 0. Patients are followed weekly for 100 days, at 6 months, and then every 6 months for 2.5 years. PROJECTED ACCRUAL: Not specified
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /55 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following histologically confirmed diseases: - Acute myeloid leukemia (AML) - In first, second, or greater remission - In early relapse (less than 30% marrow blasts) - Acute lymphoblastic leukemia (ALL) - In second or greater complete remission - High-risk ALL in first complete remission, defined by 1 of the following factors: - t(4;11), t(9;22), or t(8;14) translocation - Extreme hyperleukocytosis (WBC greater than 500,000/mL) at presentation - Failure to achieve a complete remission after standard induction therapy - Chronic myelogenous leukemia - Myelodysplastic syndromes - Evolution to AML included - Refractory anemia with excess blasts (RAEB) - RAEB in transformation - Intermediate or high-grade lymphoma - Complete response (CR) or partial response (PR) after first or greater relapse OR - PR only after first-line therapy NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age - 55 and under Performance status - ECOG 0-2 OR - Lansky 80-100% Life expectancy - At least 3 months Hematopoietic - See Disease Characteristics Hepatic - Bilirubin less than 2.5 mg/dL - AST less than 4 times upper limit of normal - No chronic active hepatitis Renal - Creatinine no greater than 2.0 mg/dL - Creatinine clearance at least 50 mL/min by 24-hour urine collection Cardiovascular - Resting ejection fraction at least 50% - Shortening fraction greater than 28% (for small children) - No angina requiring treatment - No congestive heart failure requiring treatment - No myocardial infarction within the past year Pulmonary - FEV_1 at least 50% of predicted - Arterial partial pressure of oxygen at least 80 mm Hg by pulmonary function testing - Diffusion capacity at least 50% of predicted Other - Not pregnant or nursing - Negative pregnancy test - HIV negative - No uncontrolled diabetes mellitus - No active infection, including any of the following: - Soft tissue infection - Sinus infection - Dental infection - Fungal infection - No significant psychiatric illness that would preclude study participation - No medical complication that makes the risk of death during transplantation from nonmalignant causes greater than the risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy - At least 1 year since prior stem cell transplantation Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelNieder, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Susan Wiersma 216-844-3345
Additional Information:
Study ID Numbers: CDR0000270380; CWRU-1Y00
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054327
Other Myelodysplastic And Myeloproliferative Diseases Studies:
1. Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia and Diffuse Non-Hodgkin's Lymphoma
2. Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma
3. 506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment
4. Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
5. Comparison of Antibody Therapies in Treating Patients With Graft- Versus-Host Disease That Does Not Respond to Steroid Therapy
Related Studies:
Other myelodysplastic and myeloproliferative diseases Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Donor Stem Cell Transplantation in Treating Patients With Hematologic Cancer
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