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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00238368 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy with an autologous stem cell or bone marrow transplant may allow more chemotherapy to be given so that more cancer cells are killed. Procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET) (done during chemotherapy) may help doctors predict a patient's risk of relapse and help plan the best treatment.
PURPOSE: This phase II trial is studying how well FDG-PET works in predicting risk of relapse in patients with aggressive non-Hodgkin's lymphoma who are undergoing combination chemotherapy with or without autologous stem cell or bone marrow transplant.
Condition | Intervention | Phase |
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Lymphoma |
Drug: busulfan Drug: cisplatin Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: fludeoxyglucose F 18 Drug: methylprednisolone Drug: prednisone Drug: rituximab Drug: vincristine sulfate Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: positron emission tomography Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Autologous Blood or Marrow Transplantation for Aggressive Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning |
Estimated Enrollment: | 55 |
Study Start Date: | February 2004 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
After completion of study treatment, patients are followed at 4 weeks, every 3 months for 2 years, every 6 months for 1 year, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:
Must have adequate staging of disease by the following techniques:
None of the following aggressive non-Hodgkin's subtypes are allowed:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu |
Study Chair: | Lode J. Swinnen, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000445618, JHOC-J0348, JHOC-03082605 |
Study First Received: | October 12, 2005 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00238368 |
Health Authority: | Unspecified |
contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage I adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma contiguous stage II grade 3 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma stage I grade 3 follicular lymphoma |
stage III grade 3 follicular lymphoma stage IV grade 3 follicular lymphoma anaplastic large cell lymphoma stage I adult T-cell leukemia/lymphoma stage II adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma |
Prednisone Methylprednisolone Lymphoma, small cleaved-cell, diffuse Lymphoma, Follicular Prednisolone acetate Cyclophosphamide Etoposide phosphate Lymphoma, large-cell Leukemia Cisplatin Lymphoma, Large-Cell, Anaplastic Aggression Lymphoma Etoposide Cytarabine |
Methylprednisolone Hemisuccinate Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Leukemia-Lymphoma, Adult T-Cell Methylprednisolone acetate Vincristine Doxorubicin Lymphatic Diseases Busulfan Prednisolone Leukemia, T-Cell Anaplastic large cell lymphoma Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Antimetabolites Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Antibiotics, Antineoplastic Hormones Neuroprotective Agents Therapeutic Uses Alkylating Agents |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Gastrointestinal Agents Antimitotic Agents Glucocorticoids Protective Agents Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Autonomic Agents Tubulin Modulators Myeloablative Agonists |