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LYMPHOMA
New Drug Against Non-Hodgkinís Lymphoma
T607-007: A phase-II study of intravenous T900607-sodium in subjects with previously treated non-Hodgkinís lymphoma. The drug inhibits the growth of a broad variety of tumor cell lines, including those with acquired resistance to other chemotherapeutics. Closed to accrual.
Sponsor: Tularik, Inc.
Principal Investigator: Dr. John Leonard
0502-284
Targeted Radiotherapy Against Non-Hodgkinís Lymphoma
CP-98-028: Phase-I, dose-escalation study of iodine-131 (a radioactive form of iodine) fused with anti-B1 antibody. The antibody is a protein designed to lock onto a lymphoma cell so that the radioactive iodine can kill it. For patients with previously treated non-Hodgkinís lymphoma involving more than 25 percent of the bone marrow. Closed to accrual.
Sponsor: Corixa Corp.
Principal Investigator: Dr. John Leonard
0499-637
Large B-Cell Lymphoma
CP-99-032: Phase-II multicenter study of iodine-131 (a radioactive form of iodine) consolidated with an anti-B1 antibody. The antibody is a protein designed to seek out a lymphoma cell so that the radioactive iodine can kill it. For patients with diffuse large B-cell non-Hodgkinís lymphoma following first-line combination chemotherapy with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone). Jan-00 through Dec-04. Closed to accrual.
Principal Investigator: Dr. John Leonard
0100-028
Chronic Lymphocytic Leukemia
Phase-I study of bryostatin-1 and fludarabine in patients with chronic lymphocytic leukemia, the most common form of leukemia, and indolent non-Hodgkinís lymphoma. Nov-99 through Nov-04. Also listed under leukemia.
Principal Investigator: Dr. Eric Feldman
1199-937
Lymphoma Vaccine
Genitope 2003: A phase-III trial to evaluate the safety of an immunotherapy in which a protein specific to certain lymphoma cells is joined to a carrier protein called KLH. The fused proteins are then injected subcutaneously along with a factor called GM-CSF, which boosts the bodyís population of white blood cell and thereby enhances the immune systemís anti-lymphoma assault. For patients with follicular non-Hodgkinís lymphoma.
Sponsor: Genitope Corp.
Principal Investigator: Dr. John Leonard
0101-542
Lymphoma Vaccine after Rituxan
Genitope 2002-09: A phase-II trial similar to the above for patients with follicular non-Hodgkinís lymphoma who have previously been treated with the monoclonal antibody rituximab (Rituxan).
Sponsor: Genitope Corp.
Principal Investigator: Dr. John Leonard
Rituximab Plus Interleukin-2
Chiron IL2NHL03: An open-label, phase II/III study of the monoclonal antibody rituximab in combination with recombinant human interleukin-2, a substance normally made by white blood cells to activate cells of the immune system and stimulate them to reproduce. For relapsed low-grade or follicular non-Hodgkin's lymphoma in subjects who have previously failed rituximab.
Sponsor: Chiron, Inc.
Principal Investigator: Dr. John Leonard
0402-249
AMG 412 Against Non-Hodgkinís Lymphoma
AMG20010116: A phase-III trial of immunotherapy with AMG 412 (epratuzumab) in patients with low-grade, follicular, B-cell non-Hodgkinís lymphoma refractory to Rituxan (rituximab). AMG 412 is a recently developed monoclonal antibody that targets a cell-surface molecule on non-Hodgkinís lymphoma cells and has been shown to be effective in some patients for whom Rituxan has had no therapeutic effect. Closed to accrual.
Sponsor: Amgen Corp.
Principal Investigator: Dr. John Leonard
0900-398
AMG412 with Rituxan Against Non-Hodgkinís Lymphoma
Amgen 20010138: A phase-II clinical trial combining two monoclonal antibodies -- AMG412 and rituximab (Rituxan) -- in patients that have not been treated with rituximab and who have refractory or recurrent low-grade B-cell non-Hodgkinís lymphoma. AMG412 has been shown to be effective in some patients for whom Rituxan has had no therapeutic effect. Closed to accrual.
Sponsor: Amgen, Inc.
Principal Investigator: Dr. John Leonard
1001-936
AMG412 Against Non-Hodgkinís Lymphoma
Amgen 20010159: A phase-II, open-label, randomized clinical trial of immunotherapy with AMG 412, a recently developed monoclonal antibody that sometimes proves effective where Rituxan has not. For subjects with diffuse large B-cell non Hodgkinís lymphoma. Closed to accrual.
Sponsor: Amgen, Inc.
Principal Investigator: Dr. John Leonard
1201-995
Hu1D10 Against Non-Hodgkinís Lymphoma
Protein Design Labs 1D10-901: A phase II open-label, randomized, multicenter trial to provide a preliminary evaluation of the safety and efficacy of Hu1D10. This monoclonal antibody is produced to target a specific structure on the surface of B-lymphocytes and thereby initiate programmed cell death (apoptosis) a natural process by which the body rids itself of unwanted cells . The study is open to patients with relapsed or refractory grades I, II, or III B-cell non-Hodgkinís lymphoma (including small lymphocytic and marginal-zone/MALT). Closed to accrual.
Principal Investigator: Dr. John Leonard
0101-552
FavId Against B-Cell Lymphomas
FavId-01: A phase-II study of FavId (tumor-specific idiotype) administered with KLH and soluble GM-CSF. Cancerous B-cells have proteins on their surface called idiotypes (Id) that are not found on normal B-cells and therefore serve as an ideal target for the bodyís immune system. To augment the immune response, the Id protein is coupled to a strongly immunogenic protein called KLH and administered with GM-CSF, an agent that boosts the immune systemís production of white blood cells. The trial is open to patients with stable or progressive low-grade follicular B-cell lymphomas who have received prior chemotherapy or treatment with monoclonal antibodies (for example Rituxan). Closed to accrual.
Sponsor: Favrille, Inc.
Principal Investigator: Dr. John Leonard
1101-989
CPG 7909 Against Non-Hodgkinís Lymphoma
Coley Pharmaceuticals #C004: A multi-center, phase-I, open-label, two-arm, non-randomized, dose-escalation study of the safety and tolerability of CPG 7909 in patients receiving Rituxan for relapsed or refractory B-cell non-Hodgkinís lymphoma. CPG 7909 is a promising agent for strengthening the bodyís immune response to cancer. Closed to accrual.
Sponsor: Coley Pharmaceuticals
Principal Investigator: Dr. John Leonard
1201-020
Follicular Lymphoma
IDEC-114-20: A phase I/II trial of the monoclonal antibody IDEC-114 for patients with relapsed or refractory follicular lymphoma. The antibody targets a prominent molecule called CD80 on the surface of lymphoma cells. Closed to accrual.
Sponsor: IDEC Pharmaceuticals
Principal Investigator: Dr. John Leonard
1201-021
Depsipeptide Against T-Cell Lymphoma
NCI 1312: Phase-II trial of depsipepeptide in patients with cutaneous T-cell lymphoma and relapsed peripheral T-cell lymphoma. Depsipeptide is a new drug that has been shown to kill cancer cells in laboratory studies and to shrink various kinds of tumors in animal models. This study will evaluate the response of T-cell lymphomas to depsipeptide and determine how well patients tolerate the drug.
Consortium: Weill Cornell (open), NYU (distributed), Mt. Sinai (distributed), North Shore (distributed), Montefiore (distributed)
Sponsor: National Cancer Institute
0402-216
Genasense and Chemotherapy
Genta GL212: Phase-II, multicenter study of Genasense alone or in combination with the monoclonal antibody rituximab and four chemotherapeutic agents -- cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP). Resistance to anticancer therapy is sometimes associated with the presence in cancer cells Bcl-2, a protein that prevents programmed cell death (apoptosis). Genasense turns off the production of Bcl-2 and thereby may increase a tumor cellís sensitivity to therapy and bring about its death. This study, expected to start soon, is for patients with newly diagnosed, refractory, or relapsed mantle cell lymphoma.
Sponsor: Genta Incorporated
Principal Investigator: Dr. John Leonard
0402-203
EPOCH-Rituximab Against Non-Hodgkinís Lymphoma
CALGB50103: Phase-II study of dose-adjusted EPOCH-rituximab (EPOCH-R). The chemotherapy regimen EPOCH-rituximab, administered intravenously, consists of the following drugs: rituximab, doxorubicin, etoposide, vincristine, cyclophosphamide, prednisone, and G-CSF. Rituximab (Rituxan) is a monoclonal antibody, a protein designed to recognize specific cell-surface proteins on cancer cells and target it for attack. Rituximab targets the protein CD20, which is often found on cancerous B-cell lymphocytes in several types of non-Hodgkinís lymphoma. The study enrolls patients with untreated, aggressive, CD20-positive, B-cell non-Hodgkin's lymphoma.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigator: Dr. John Leonard
0702-362
Study of Genetic Changes
CALGB9764: This companion study to CALGB 50103 monitors genetic changes in diffuse aggressive non-Hodgkin's lymphoma.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigators: Drs. Scott Wadler and John Leonard
0702-369
Aggressive, Comprehensive Treatment for Mantle Cell Lymphoma
CALGB59909: A study of intensive induction chemotherapy followed by autologous stem cell transplantation plus immunotherapy for mantle cell lymphoma. The purpose of this study is to determine the success of this aggressive, comprehensive treatment in achieving two-year progression-free survival of patients with newly diagnosed, untreated mantle cell lymphoma or patients who have received just one prior chemotherapy/rituximab treatment. Autologous stem cell transplantation involves removal of white blood cells from the patientís peripheral circulation then reinfusion of the cells after the patient receives high-dose chemotherapy.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigator: Dr. Scott Wadler
0802-405
Combination Therapies for Hodgkinís Disease
CALGB 59905: A randomized phase-III trial of ABVD versus Stanford V+/- radiation therapy in locally extensive and advanced stage Hodgkin's disease with 0-2 risk factors.
One group of patients will receive ABVD (doxorubicin, bleomycin, vinblastine, dacarbazeine) and the other will receive a combination known as Stanford V, consisting of the first four drugs above plus nitrogen mustard, etoposide, and prednisone. Both groups will then receive radiation therapy, which will vary on an individual basis.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigators: Drs. Scott Wadler and John Leonard
0902-454
Three-Drug Combination for Hodgkinís Disease
CALGB59804: Phase I/II study of a three-drug combination consisting of gemcitabine (Gemzar), vinorelbine (Navelbine), and liposomal doxorubicin (Doxil) in relapsed or refractory Hodgkin's disease. Although approved by the FDA as individual agents, the three drugs have not been given previously together, and the studyís purpose is to test the safety and effectiveness of the combination regimen.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigators: Drs. Scott Wadler and John Leonard
0902-466
Two-Drug Combination for Non-Hodgkinís Lymphoma
CALGB59906: A phase-II study of sequential doxorubicin and topotecan in relapsed or refractory intermediate or high-grade non-Hodgkin's lymphoma. For patients whose cancer has returned after having been treated with chemotherapy or radiation therapy.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigators: Drs. Scott Wadler and John Leonard
0902-480
Combined Antibody Therapy for Follicular Lymphoma
A phase-I/II trial of IDEC-114 and Rituxan for patients with relapsed or refractory follicular lymphoma. This therapy combines two monoclonal antibodies, each of which targets a different molecule on the surface of lymphoma cells.
Sponsor: IDEC Pharmaceuticals
Principal Investigator: Dr. John Leonard
0902-447
Gallium Nitrate Against Non-Hodgkinís Lymphoma
Phase-II, multicenter study of gallium nitrate in patients with refractory non-Hodgkinís lymphoma. Gallium appears to target lymphoma cells preferentially, and, unlike most chemotherapeutic drugs, it does not suppress the bone marrow. Several clinical trials have suggested that the drug produces a better than 40-percent response rate in patients with refractory non-Hodgkinís lymphoma.
Sponsor: Genta Incorporated
Principal Investigator: Dr. John Leonard
1002-529
Antibody Against Blood Malignancies
SG030-0002: A phase-I/II, multi-dose study of SGN-30 in patients with refractory or recurrent CD30+ hematologic malignancies. This study is designed to identify the safety and effectivness of a monoclonal antibody that targets a cell-surface molecule, CD30, found in a variety of blood cancers.
Sponsor: Seattle Genetics
Principal Investigator: Dr. John Leonard
1102-565
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