|
Total-Body Irradiation, Fludarabine, and Peripheral 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 Total-Body Irradiation, Fludarabine, and Peripheral 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. Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer Clinical research trials and Total-Body Irradiation, Fludarabine, and Peripheral 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 Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer. Total-Body Irradiation, Fludarabine, and Peripheral 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 Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer clinical trial. Human subjects often get the best healthcare possible for their Total-Body Irradiation, Fludarabine, and Peripheral 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.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer  Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
For Condition: plasma cell neoplasm,myelodysplastic and myeloproliferative diseases,Leukemia,Lymphoma
Status: Recruiting
Sponsor(s): Simmons Cancer Center ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have hematologic cancer.
Details: OBJECTIVES: - Determine the response rate and duration of response in patients with low-risk hematologic malignancies treated with low-dose total-body irradiation (TBI) and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a slow immunosuppression taper and donor leukocyte infusions (DLI). - Determine the response rate and duration of response in patients with high-risk hematologic malignancies treated with low-dose TBI and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a faster immunosuppression taper and DLI. - Determine the incidence and extent of graft-versus-host disease, regimen-related toxicity, and engraftment in patients treated with these regimens. - Assess the quality of life of patients treated with these regimens. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups (high-risk vs low-risk hematologic malignancy). The high-risk group includes acute myelogenous leukemia, myelodysplastic syndromes, accelerated phase chronic myelogenous leukemia (CML), second chronic phase CML, and non-Hodgkin's lymphoma. The low-risk group includes Hodgkin's lymphoma, first chronic phase CML, multiple myeloma, and chronic lymphocytic leukemia. Patients receive fludarabine IV on days -4 to -2. Patients undergo total-body irradiation on day 0 followed by allogeneic stem cell transplantation. Patients also receive oral mycophenolate mofetil on days 0-28. High-risk patients receive oral cyclosporine twice daily on days -2 to day 60. Patients with persistent disease, T-cell chimerism, and no graft-vs-host disease (GVHD) on day 90 receive up to 3 doses of donor leukocyte infusion (DLI) over the next 4 months. Low-risk patients receive oral cyclosporine twice daily on days -2 to day 150. Patients with persistent disease, T-cell chimerism, and no GVHD on day 180 receive up to 3 doses of DLI over the next 4 months. Quality of life is assessed at baseline and at 1, 3, 6, 9, 12, 18, and 24 months. Patients are followed at 1, 3, 6, 9, and 12 months and then annually for 2 years. PROJECTED ACCRUAL: A total of 120 patients (60 per group) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of one of the following hematologic malignancies: - Chronic myelogenous leukemia (CML) - First or second chronic phase - Accelerated phase - Acute myelogenous leukemia (AML) - At least second remission - First remission allowed if poor-risk features are present (complex chromosome karyotype, abnormalities of chromosomes, especially 5 or 7, 12p-, +13, +8, t[9:11]) - Myelodysplastic syndromes (MDS) - Intermediate- or high-risk disease by the prognostic scoring system - Multiple myeloma (MM) - Hodgkin's lymphoma - Second or greater relapse - First relapse allowed if disease-free interval is less than 1 year - Ineligible for autologous transplantation - Non-Hodgkin's lymphoma (NHL) - Grade III follicular large cell (relapsed after one course of prior chemotherapy) - Diffuse large cell (relapsed after one course of prior chemotherapy) - Mantle cell - Chronic lymphocytic leukemia (CLL) - Relapsed after at least 1 course of prior therapy - Must have 6 out of 6 HLA A-, B-, and DR- identical sibling donor PATIENT CHARACTERISTICS: Age - 18 to 75 for patients with MM - 50 to 75 for patients with CML, AML, MDS, Hodgkin's lymphoma, NHL, or CLL - 18 to 49 for patients with CML, AML, MDS, Hodgkin's lymphoma, NHL, or CLL who are considered eligible for an allogeneic bone marrow transplantation (BMT) but do not meet institutional criteria for a standard allogeneic BMT Performance status - Zubrod 0-2 Life expectancy - At least 6 months Hematopoietic - Not specified Hepatic - Bilirubin no greater than 3 mg/dL Renal - Creatinine no greater than 2 mg/dL Cardiovascular - LVEF at least 40% by MUGA or echocardiogram Pulmonary - DLCO at least 50% of predicted Other - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No recent history of drug or alcohol abuse - No other prior malignancy except basal cell skin cancer - No uncontrolled bacterial, viral, fungal, or parasitic infections PRIOR CONCURRENT THERAPY: Biologic therapy - Prior autologous transplantation allowed if disease progression occurred - No prior or concurrent tandem autologous transplantation followed by non-myeloablative-allograft protocol Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertCollins, Study Chair, Simmons Cancer Center
Blood and Marrow Transplant Group of Georgia *Recruiting*
Atlanta, Georgia, 30342-4777
United States
Recruiting Gerard Connaghan 404-255-1930
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75235-8590
United States
Recruiting Robert Collins 214-648-7702
Florida Hospital Cancer Institute *Recruiting*
Orlando, Florida, 32804
United States
Recruiting John Edwards 407-303-2070
Massey Cancer Center at Virginia Commonwealth University *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John McCarty 804-828-4360
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Mark Juckett 608-263-1836
St. Joseph's Hospital and Medical Center *Recruiting*
Paterson, New Jersey, 07503
United States
Recruiting Arnold Rubin 973-754-2432
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting Margarida Magalhaes-Silverman 319-384-9156
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting Richard Maziarz 503-494-6345
Texas Transplant Institute *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Paul Shaughnessy 210-575-8500
Cancer Center at Hackensack University Medical Center *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Scott Rowley 201-996-5900
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting J.J. Ifthikharudin 585-275-4099
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Steven Goldstein 813-979-7202
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37212
United States
Recruiting Madhuri Vusirikala 615-321-6373
Kansas City Cancer Centers - Central *Recruiting*
Kansas City, Missouri, 64111
United States
Recruiting Joseph McGuirk 816-531-2740
Rocky Mountain Cancer Centers - Midtown *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Robert Rifkin 303-388-4876
Additional Information:
Study ID Numbers: CDR0000069461; ROCHE-UTSMC-0799296,UTSMC-0799296,IBMTR-SC-00-03.1,SPRI-UTSMC-0799296,AMGEN-UTSMC-0799296,NCI-V02-1705
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044954
Other Leukemia Studies:
1. Combination Chemotherapy Plus Infusion of White Blood Cells in Treating Patients With Hematologic Cancer
2. Donor Stem Cell Transplantation in Treating Patients With Hematologic Cancer
3. Donor Umbilical Cord Blood Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
4. Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia
5. High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Related Studies:
Other Leukemia Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
|
|
|
|
|
|
|
|
