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TRANSPLANT-RELATED TRIALS
Therapies for Graft-Versus-Host Disease
This randomized trial compares two regimens for combating graft-versus-host disease (in which transplanted white blood cells attack the recipientís cells) following peripheral blood stem-cell transplantation from matched donors to patients with advanced blood malignancies. One group of patients receives cyclosporine and methotrexate and the other group is treated with cyclosporine combined with T-cell depletion.
Principal Investigator: Dr. Michael Schuster
0200-101
Stem-Cell Transplantation
Ongoing study of autologous peripheral blood stem-cell transplantation for chronic myelogenous leukemia. (Also listed under leukemia)
Principal Investigator: Dr. Michael Schuster
0698-287
High-Dose Chemotherapy with Hematopoietic Support for Advanced Myeloma
This phase-II trial combines high-dose carmustine and melphalan combined with hematopoietic support for the treatment of advanced-stage multiple myeloma. In high-dose regimens, chemotherapy is given in doses considerably greater than conventional ones for the purpose of killing the greatest possible number of cancer cells. Damage to bone marrow can be eliminated or lessened by harvesting the patientís hematopoietic (blood-making) stem cells and reinfusing them after high-dose chemotherapy to repopulate the bone marrow.
Principal Investigator: Dr. Ruben Niesvizky.
0900-396
Non-Myeloablative Conditioning Followed by Stem Cell Transplant for Blood Cancers
A study of non-myeloablative conditioning followed by allogeneic stem-cell transplant for patients with hematological malignancies. Until recently a stem-call transplant for older patients was relatively rare because of the rigors of the pre-transplant conditioning. Now transplant physicians have developed less strenuous conditioning regimens, called non-myeloablative transplants because they do not completely destroy the patientís diseased marrow. This procedure has the further advantage of initiating a phenomenon called graft-versus-malignancy effect, in which the recipientís new immune system (originating from the donated stem cells) attacks cancer cells. To limit damage to normal cells from the donor-derived cells, patients receive the monoclonal antibody Compath.
Principal Investigator: Dr. Tsiporah Shore
0402-256
Visilizumab Against Graft-Versus-Host Disease
This phase-II study evaluates the humanized monoclonal antibody visilizumab (Nuvion) as a second line therapy against graft-versus-host disease refractory to standard treatment with glucocorticoids. Patients will be allowed to continue on their other immunosuppressive drugs at stable doses during the trial.
Sponsor: Protein Design Labs
Principal Investigator: Dr. Shambavi Richard
0602-308
Immunologic Rinse for Oral Mucositis
This randomized, phase-II trial tests the effectiveness of a new agent to prevent inflammation of the mouth in patients who are undergoing intensive radiation or chemotherapy to kill malignant cells in anticipation of autologous stem-cell transplantation.
Principal Investigator: Dr. Shambavi Richard
0502-273
Stem Cell Transplantation for Metastatic Renal Cell Cancer
CALGB 90003: Phase-II trial of adoptive immunotherapy by allogeneic stem cell transplantation for metastatic renal-cell carcinoma. In an approach that has proved effective in some cases with extremely poor prognoses, stem cells from a matched donor are administered to the patient, so that the transplanted cells can produce lymphocytes that will attack the cancer. The drug tacrolimus is administered twice daily to limit damage to normal cells via graft-versus-host disease.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigator: Dr. Scott Wadler
0802-396
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