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LEUKEMIA
Stem-Cell Transplantation
This trial seeks to determine the safety and efficacy of using high-density microparticles to remove attack cells from among transplanted donor lymphocytes. The studyís purpose is to reduce graft-versus-host disease without compromising an anti-leukemia effect in patients with chronic myeloid leukemia. To be tested in connection with peripheral blood stem-cell transplants from identical siblings after non-myeloablative conditioning (Jun-00 through Jun-03)
Principal Investigator: Dr. Michael Schuster
0599-699
Stem-Cell Transplantation
Ongoing study of autologous peripheral blood stem-cell transplantation for chronic myelogenous leukemia. (Also listed in transplant-related trials)
Principal Investigator: Dr. Michael Schuster
0698-287
Gleevec
STI-106: The new drug Gleevec (also known as imatinib mesylate and by its experimental name STI571) has shown unprecedented effectiveness against chronic myeloid leukemia. This study focuses on the efficacy and safety of Gleevec in patients with chronic myeloid leukemia who are resistant to or intolerant of another widely used therapy, interferon alfa. Closed to accrual.
Sponsor: Novartis Pharmaceuticals
Principal Investigator: Dr. Richard Silver
0500-205
Gleevec
STI-110: A phase-II study to determine the efficacy and safety of STI571 (Gleevec) in patients with chronic myeloid leukemia who are refractory to or intolerant of interferon alfa. Closed to accrual.
Sponsor: Novartis Pharmaceuticals
Principal Investigator: Dr. Richard Silver
0100-033
Gleevec
STI-109: A two-year extension of a phase-II study to determine the safety and anti-leukemia efficacy of STI571 (Gleevec) in adult patients positive for the Philadelphia chromosome, a chromosomal abnormality seen most commonly in chronic myeloid leukemia but sometimes in other leukemias. The study enrolls patients with acute lymphoblastic leukemia, acute myeloid leukemia, lymphoid blast crisis, chronic myeloid leukemia, and accelerated-phase of chronic myeloid leukemia. Closed to accrual.
Sponsor: Novartis Pharmaceuticals
Principal Investigator: Dr. Richard Silver
0999-870
Relapsed Acute Leukemia
CPTK787-0130: A phase-IA, open-label, dose-escalation study of the experimental drug PTK787/ZK 222584, an oral agent that interferes with receptor proteins found on the surface of leukemic cells. This trial is for patients with relapsed or refractory acute myeloid leukemia (AML); patients with secondary AML; patients with advanced myelodysplastic syndrome (RAEB and RAEBT); or elderly patients with de novo AML who have a poor prognosis.
Sponsor: Novartis Pharmaceuticals
Principal Investigator: Dr. Gail Roboz
0701-824
PSC 833 for Acute Myeloid Leukemia
CALGB19808: Randomized phase-III trial for patients with acute myeloid leukemia to determine the effectiveness of combined-drug chemotherapy administered with or without PSC 833, an investigational drug that has shown effectiveness in reversing multidrug resistance in cancer cells. The study tests whether PSC 833 increases the effectiveness of chemotherapy in leading to remissions and long-term survival when followed up with high-dose chemotherapy, peripheral stem-cell transplantation, and administration of interleukin-2. For patients under 60 years of age.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigator: Dr. Scott Wadler
0301-640
Chronic Lymphocytic Leukemia
Genta CL303: Randomized study for patients with relapsed or refractory chronic lymphocytic leukemia in which the chemotherapeutic drugs fludarabine and cyclophosphamide are administered with or without Genasense (Bcl-2 antisense oligonucleotide). Resistance to anticancer therapy is sometimes associated with the presence in cancer cells of a protein called Bcl-2. Genasense is a drug that turns off the production of the Bcl-2 protein and thereby may increase a tumor cell's sensitivity to therapy and cause programmed cell death (also called apoptosis), a natural process by which the body rids itself of unwanted cells.
Principal Investigator: Dr. John Leonard
0501-731
Understanding Resistance to Therapy in AML
CALGB 9760: This study of multidrug resistance in acute myeloid leukemia seeks to improve understanding of why leukemic cells are sometimes resistant to chemotherapy or become so in the course of treatment. For the purposes of this study, a slightly extra amount of blood or marrow is drawn from volunteers in the course of normal treatment.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigator: Dr. Scott Wadler
0597-821
Tissue Bank
CALGB 9665: The CALGB Leukemia Tissue Bank collects and stores specimens from every newly diagnosed patient with acute or chronic leukemia or myelodysplastic syndrome who is entered on a CALGB protocol for previously untreated patients.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigator: Dr. Scott Wadler
0896-438
Cytogenetic Studies
CALGB 8461: Cytogenetic studies in acute leukemia and myelodysplastic syndromes. The purpose is to determine the incidence of primary and secondary chromosome abnormalities in adult acute myeloid leukemia, acute lymphocytic leukemia, and myelodysplastic syndromes and to correlate them with clinical and laboratory parameters.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigator: Dr. Scott Wadler
0894-551
Advanced Myelodysplastic Syndrome
SCH66336: Phase I/II study of continous oral administration of SCH66336 in patients with advanced myelodysplastic syndrome, acute myelogenous leukemia, chronic myelogenous leukemia in blast crisis, and acute lymphoblastic leukemia. SCH66336 is an inhibitor of the enzyme farnesyl transferase, which is needed for the activation of a growth-promoting gene called ras that has been implicated in a number of cancers. Closed to accrual.
Sponsor: Schering Plough Pharmaceuticals
Principal Investigator: Dr. Richard Silver
0701-810
Genetics of Acute Lymphoblastic Leukemia
CALGB 9862: Molecular genetic features of acute lymphoblastic leukemia (ALL). Previous research suggests that ALL is divided into groups based on certain characteristics of the chromosomes in the leukemia cells. This study investigates whether patients' responses to treatment are related to these chromosomal types.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigator: Dr. Scott Wadler
0902-500
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 lymphoma.
Principal Investigator: Dr. Eric Feldman
1199-937
Thymoglobulin Therapy
This phase-IIB, multicenter, randomized study probes the impact of thymoglobulin therapy on transfusion needs of patients with early myelodysplastic syndrome.
Sponsor: SangStat Medical Corp.
Principal Investigator: Dr. Michael Schuster
0700-332
Acute Promyelocytic Leukemia
A phase-III, randomized trial comparing the efficacy and toxicities of two induction therapies (that is, initial treatments) and two maintenance therapies for patients with untreated APL. The induction therapies are tretinoin (ATRA) in combination with the chemotherapeutic drugs cytarabine and daunorubicin with or without arsenic trioxide. Patients achieving complete or partial response proceed to one of two maintenance therapies: intermittent ATRA versus intermittent ATRA plus mercaptopurine and methotrexate. Tretinoin (ATRA) is a vitamin-A derivative which induces tumor cells to differentiate into mature cells that do not proliferate abnormally.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigator: Dr. Scott Wadler
0702-368
Gleevec
Phase-II trial of a sequence consisting of chemotherapy, imatinib mesylate (Gleevec), and transplantation for adults with newly diagnosed acute lymphoblastic leukemia that is positive for the Philadelphia chromosome.
Sponsors: Cancer and Leukemia Group B and Southwestern Oncology Group
Principal Investigator: Dr. Scott Wadler
0802-409
Polycythemia Vera
Phase-II study of the treatment of polycythemia vera with Gleevec. In initial trials, patients have enjoyed a considerable reduction in the need for phlebotomies, currently the principal treatment for this disease.
Sponsor: Novartis Pharmaceuticals
Principal Investigator: Dr. Richard Silver
0702-375
Refractory Acute Myeloid Leukemia
A phase-I, open-label, single arm, multi-center study of troxacitabine administered by continuous infusion in subjects with refractory acute myeloid leukemia (AML). Troxacitabine has demonstrated significant antileukemic activity in patients with AML and chronic myeloid leukemia, blast phase.
Sponsor: Shire Pharmaceuticals
Principal Investigator: Dr. Eric Feldman
1102-568
Gleevec plus Genasense
A phase-II study of G3139 Genasense plus Gleevec in patients with Gleevec-resistant chronic myeloid leukemia. Resistance to anticancer therapy is sometimes associated with the presence in cancer cells of Bcl-2, a protein that prevents programmed cell death (apoptosis), the process by which the body rids itself of unwanted cells. Genasense turns off the production of Bcl-2 and thereby may increase cancer cellsí sensitivity to Gleevec and increase the likelihood of apoptosis.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigator: Dr. Scott Wadler
0103-643
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