Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00723658 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Biological: rituximab Drug: bortezomib Drug: carmustine Drug: cisplatin Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide Drug: melphalan Drug: thalidomide Procedure: autologous-autologous tandem hematopoietic stem cell transplantation Procedure: observation Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Observational Study of Asymptomatic Waldenstrom's Macroglobulinemia and Phase II Study of Tandem Autologous Transplant and Maintenance Treatment for Patients With Symptomatic Disease |
Estimated Enrollment: | 50 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients with asymptomatic disease at study entry proceed directly to observation. Patients with symptomatic disease at study entry proceed directly to induction therapy.
First autologous PBSC transplantation*: Beginning approximately 4-6 weeks after the completion of induction therapy, patients receive conditioning therapy comprising high-dose melphalan IV and bortezomib IV on days -4 and
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must be registered to the treatment portion of the study within 28 days of experiencing disease-related symptoms* AND must present with ≥ 1 of the following disease-related symptoms:
PATIENT CHARACTERISTICS:
Ejection fraction ≥ 50% by ECHO or MUGA scan
PRIOR CONCURRENT THERAPY:
United States, Indiana | |
Reid Hospital & Health Care Services | Recruiting |
Richmond, Indiana, United States, 47374 | |
Contact: Howard M. Gross, MD 937-832-1093 | |
St. Francis Hospital and Health Centers - Beech Grove Campus | Recruiting |
Beech Grove, Indiana, United States, 46107 | |
Contact: Howard M. Gross, MD 937-832-1093 | |
United States, Kansas | |
Wesley Medical Center | Recruiting |
Wichita, Kansas, United States, 67214 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
United States, Ohio | |
Blanchard Valley Medical Associates | Recruiting |
Findlay, Ohio, United States, 45840 | |
Contact: Howard M. Gross, MD 937-832-1093 | |
CCOP - Dayton | Recruiting |
Dayton, Ohio, United States, 45429 | |
Contact: Howard M. Gross, MD 937-832-1093 | |
Charles F. Kettering Memorial Hospital | Recruiting |
Kettering, Ohio, United States, 45429 | |
Contact: Clinical Trials Office - Charles F. Kettering Memorial Hospita 937-298-3399 ext. 57556 | |
Clinton Memorial Hospital | Recruiting |
Wilmington, Ohio, United States, 45177 | |
Contact: Howard M. Gross, MD 937-832-1093 | |
Wayne Hospital | Recruiting |
Greenville, Ohio, United States, 45331 | |
Contact: Howard M. Gross, MD 937-832-1093 | |
Good Samaritan Hospital | Recruiting |
Dayton, Ohio, United States, 45406 | |
Contact: Howard M. Gross, MD 937-832-1093 | |
Grandview Hospital | Recruiting |
Dayton, Ohio, United States, 45405 | |
Contact: Howard M. Gross, MD 937-832-1093 | |
Middletown Regional Hospital | Recruiting |
Franklin, Ohio, United States, 45005-1066 | |
Contact: Howard M. Gross, MD 937-832-1093 | |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Recruiting |
Xenia, Ohio, United States, 45385 | |
Contact: Howard M. Gross, MD 937-832-1093 | |
UVMC Cancer Care Center at Upper Valley Medical Center | Recruiting |
Troy, Ohio, United States, 45373-1300 | |
Contact: Clinical Trials Office - UVMC Cancer Care Center at Upper Vall 937-440-4842 | |
Veterans Affairs Medical Center - Dayton | Recruiting |
Dayton, Ohio, United States, 45428 | |
Contact: Howard M. Gross, MD 937-832-1093 | |
David L. Rike Cancer Center at Miami Valley Hospital | Recruiting |
Dayton, Ohio, United States, 45409 | |
Contact: Clinical Trials Office - David L. Rike Cancer Center at Miami 937-208-2079 |
Study Chair: | Gordan Srkalovic, MD, PhD | Sparrow Regional Cancer Center |
Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
Study ID Numbers: | CDR0000600963, SWOG-S0629 |
Study First Received: | July 26, 2008 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00723658 History of Changes |
Health Authority: | Unspecified |
Waldenstrom macroglobulinemia |
Anti-Inflammatory Agents Antimetabolites Dexamethasone Anti-Infective Agents Melphalan Immunologic Factors Thalidomide Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones |
Etoposide phosphate Anti-Bacterial Agents Hemorrhagic Disorders Cisplatin Alkylating Agents Lymphoma Etoposide Cytarabine Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Rituximab Blood Coagulation Disorders Carmustine |
Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Angiogenesis Modulating Agents Immunoproliferative Disorders Immune System Diseases |
Antineoplastic Agents, Hormonal Rituximab Hematologic Diseases Carmustine Glucocorticoids Doxorubicin Protease Inhibitors Waldenstrom Macroglobulinemia Neoplasms Leprostatic Agents Antimetabolites Thalidomide Immunologic Factors Blood Protein Disorders Antineoplastic Agents |