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Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation Clinical research trials and Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation healthcare trials occur in a lot of of places across 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 effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation. Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation clinical trial. Test subjects typically receive the most effective healthcare possible for their Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation  Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation
Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation
For Condition: Graft Versus Host Disease,Cancer
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: White blood cells from donors may be able to kill cancer cells and prevent disease progression or relapse in patients who have undergone allogeneic bone marrow transplantation or allogeneic stem cell transplantation. PURPOSE: Phase I/II trial to study the effectiveness of donor lymphocyteinfusion in treating patients who have persistent, relapsed, or progressing cancer after allogeneic bone marrow transplantation or stem cell transplantation.
Details: OBJECTIVES: Primary - Determine the safety of donor lymphocyte infusion, in terms of the incidence of life-threatening graft-versus-host disease (GVHD), in patients with persistent, relapsed, or progressing malignancy after nonmyeloablative allogeneic transplantation. Secondary - Determine disease response and progression-free and overall survival of patients treated with this regimen. - Determine chimerism in patients treated with this regimen. - Determine the grade of GVHD and infections in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study. Patients receive unirradiated (viable) donor lymphocyte infusion (DLI) over 15-30 minutes on day 0. Patients may receive a second infusion after 4 weeks if no graft-versus-host disease (GVHD) develops and disease worsens, or after 8 weeks if disease status is unchanged and persistent donor T cells are documented. To determine the safety of this regimen, all patients receive a standard initial dose of DLI and then, among patients requiring a second treatment, cohorts of 5-25 patients receive decreasing doses of DLI. Acceptable safety is determined by the regimen during which no more than 15% of patients experience morbid GVHD. Patients are followed every 2 months for 6 months, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 5-100 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Persistent, relapsed, or progressing malignancy - Previously treated with a nonmyeloablative allogeneic transplantation from a related or unrelated donor comprising total body irradiation with or without fludarabine - Persistent donor CD3 cells (at least 5% donor CD3 cells by fluorescent in situ hybridization or variable number of tandem repeats) - Available leukapheresis product from the original donor of the hematopoietic cell transplantation (fresh unmodified or previously cryopreserved) - No current grade II to IV acute graft-versus-host disease (GVHD) or extensive chronic GVHD PATIENT CHARACTERISTICS: Age - Any age Performance status - Karnofsky 50-100% Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Not specified Renal - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No concurrent imatinib mesylate or interferon alfa Chemotherapy - See Disease Characteristics - At least 3 weeks since prior salvage chemotherapy Endocrine therapy - Concurrent steroids allowed provided patient can tolerate a taper to a dosage of no greater than 0.25 mg/kg/day within 1 to 2 weeks prior to study therapy without experiencing an increase in GVHD of at least 1 grade Radiotherapy - See Disease Characteristics Surgery - Not specified Other - At least 2 weeks since prior immunosuppressive therapy (e.g., cyclosporine or mycophenolate mofetil) for nonadvanced malignancy (1 week for advanced malignancy)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrendaSandmaier, Principal Investigator, Fred Hutchinson Cancer Research Center
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Edward Agura 214-370-1500
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Sandra Cohen 626-359-8111
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Brenda Sandmaier 206-667-4961
Universitaet Leipzig *Recruiting*
Leipzig, , D-04103
Germany
Recruiting Dietger Niederwieser 49-341-971-3050
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Michael Pulsipher 801-585-0303
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting James Wade 414-805-4609
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting Richard Maziarz 503-494-6345
University of Torino *Recruiting*
Torino, , 10126
Italy
Recruiting Benedetto Bruno 39-11-633-4418
Additional Information:
Study ID Numbers: CDR0000327819; FHCRC-1803.00
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068718
Other Graft Versus Host Disease Studies:
1. Phase II Study of Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Patients With Lysosomal or Peroxisomal Inborn Errors of Metabolism
2. Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease
3. Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia
4. Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia
5. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
Related Studies:
Other Graft Versus Host Disease Clinical Trials
Other Utah Clinical Trials
Other Salt Lake City Clinical Trials
Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation
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