drugset
drugset / Trial / NCT00723658

S0629, Observation or Combination Chemotherapy, Bortezomib, Thalidomide, and Rituximab Followed By Two Autologous Peripheral Blood Stem Cell Transplants in Treating Patients With Waldenstrom Macroglobulinemia

NCT00723658 ↗

Phase 2 Withdrawn SWOG Cancer Research Network National Cancer Institute (NCI) · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. Giving combination chemotherapy together with bortezomib, thalidomide, and rituximab before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This observational and phase II trial is studying how well giving combination chemotherapy together with bortezomib, thalidomide, and rituximab followed by two autologous peripheral blood stem cell transplants works in treating patients with Waldenstrom macroglobulinemia.

Timeline

Start
2008-09
Primary completion
2010-05
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1 mg/m2 Intravenous
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 10 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 400 mg/m2 Intravenous
Subject Cytarabine Small molecule 400 mg/m2 Intravenous
Subject Dexamethasone Small molecule 40 mg Oral
Subject Doxorubicin Other / unclassified 10 mg/m2 Intravenous
Subject Etoposide Small molecule 40 mg/m2 Intravenous
Subject Etoposide Small molecule 200 mg/m2 Intravenous
Subject Melphalan Small molecule 140 mg/m2 Intravenous
Subject Melphalan Small molecule 200 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Thalidomide Other / unclassified 200 mg Oral
Subject carmustine Small molecule 300 mg/m2 Intravenous

Indications

lymphoma