|
Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer Clinical research trials and Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer. Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer  Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
For Condition: childhood non-Hodgkin's lymphoma,Leukemia,childhood Hodgkin's lymphoma,myelodysplastic and myeloproliferative diseases,plasma cell neoplasm,Lymphoma
Status: Recruiting
Sponsor(s): Sidney Kimmel 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. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of cyclophosphamide plus bone marrow transplantation in treating patients who have hematologic cancer.
Details: OBJECTIVES: - Determine the minimum effective dose of pretransplant cyclophosphamide to induce engraftment of haploidentical allogeneic bone marrow without the use of myeloablative conditioning in patients with hematologic malignancies. - Determine the incidence and severity of graft versus host disease and nonhematologic toxicities with this treatment regimen in these patients. - Correlate the pretreatment phenotypic and functional immunologic characteristics in these patients in relation to risk of graft rejection with this treatment regimen. OUTLINE: This is a dose-escalation study of cyclophosphamide. Patients receive fludarabine IV over 1 hour on days -6 to -2; cyclophosphamide IV over 1 hour on days -6, -5, and 3; total body irradiation on day -1; and allogeneic bone marrow transplantation on day 0. Patients also receive tacrolimus IV or orally twice a day on days 4-50; oral mycophenolate mofetil on days 4-35; and filgrastim (G-CSF) subcutaneously or IV starting on day 4 and continuing until blood counts recover. Cohorts of 3-6 patients receive escalating doses of cyclophosphamide until the minimum effective dose necessary to induce chimerism without unacceptable toxicity in these patients is determined. Patients are followed at 2 and 6 months, at one year, and then annually thereafter. PROJECTED ACCRUAL: At least 23 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Patients with any of the following diagnoses: - Chronic myelogenous leukemia - Chronic phase 1 - Failed prior interferon alfa therapy OR - Relapsed after prior autologous stem cell transplantation - Chronic phase 2 - Acute leukemia - Standard risk - Age over 60 years - Complete remission 1 (CR1) - High risk - High WBC at presentation, unfavorable cytogenetics, mixed lineage, delayed response to induction chemotherapy - CR1 - Complete remission 2 or higher - Acute lymphocytic leukemia - CR1 or higher - Myelodysplastic syndrome - Untreated OR - CR1 - Acute myeloid leukemia in CR1 - Chronic lymphocytic leukemia - Rai stage III or IV OR - Received prior autologous stem cell transplantation - Multiple myeloma - Stage II or III - Stable or progressive disease after prior chemotherapy OR - Received prior autologous stem cell transplantation - Non-Hodgkin's Lymphoma - Hodgkin's lymphoma - Ineligible for or refused autologous or standard allogeneic bone marrow transplantation - Ineligible for bone marrow transplantation from an HLA matched, sibling donor or from an HLA matched, unrelated donor - Must have an HLA mismatched, related donor (3-5 out of 6) PATIENT CHARACTERISTICS: Age: - 0.5 to 70 Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin less than 3.1 mg/dL Renal: - Not specified Cardiovascular: - Left ventricular ejection fraction at least 35% Pulmonary: - FEV - and FVC at least 40% of predicted OR - FEV_1 and FVC at least 60% in patients who have received prior thoracic or mantle radiotherapy Other: - HIV negative - No other debilitating medical or psychiatric illness that would preclude study compliance - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No prior transfusions from donor Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EphraimFuchs, Study Chair, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Ephraim Fuchs 410-955-8143
Additional Information:
Study ID Numbers: CDR0000068057; JHOC-J9966,JHOC-99110501,NCI-G00-1816
Study Start Date:
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006042
Other Plasma Cell Neoplasm Studies:
1. Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
2. Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
3. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies
4. High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
5. Peripheral Blood Lymphocyte Therapy to Prevent Lymphoproliferative Disorders Caused by Epstein-Barr Virus in Patients Who Have Undergone Transplantation
Related Studies:
Other plasma cell neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
|
|
|
|
|
|
|
|
