NCT Number: NCT00002676
Chemotherapy and Whole-Brain Radiation Therapy in Treating Patients With Primary Central Nervous System Non- Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells and may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and whole-brain radiation therapy in patients with primary central nervous system non-Hodgkin's lymphoma.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States
About this study
OBJECTIVES: I. Assess the response to CHOD (cyclophosphamide/doxorubicin/vincristine/ dexamethasone) and BVAM (carmustine/vincristine/cytarabine/methotrexate) plus whole-brain radiotherapy in patients with primary central nervous system non-Hodgkin's lymphoma (PCNSL). II. Assess the toxic effects associated with this treatment. III. Assess the survival of patients with PCNSL receiving this treatment. IV. Investigate the frequency of systemic involvement at follow-up. V. Identify factors that appear to be associated with outcome.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS: Primary central nervous system non-Hodgkin's lymphoma (PCNSL) Clinically diagnosed intracranial space-occupying lesion Pathology consistent with non-Hodgkin's lymphoma and reviewed by NCCTG Biopsy optional if characteristic history, pathognomonic neuroimaging, and cytology are consistent with malignant lymphocytes from vitrectomy, CSF, or both No occult systemic lymphoma or prior lymphoma No post-transplant lymphoproliferative disorder Disease measurable or evaluable on postoperative contrast-enhanced CT or MRI Postoperative therapy must start within 6 weeks of definitive diagnosis
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-3 Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 120,000/mm3 Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2 times normal Renal: Creatinine no greater than 1.5 times normal Cardiovascular: No heart failure No uncontrolled arrhythmia Pulmonary: No severe pulmonary failure Other: No serious uncontrolled infection No active bleeding No AIDS or HIV-positive serology No prior organ transplant No pregnant or nursing women Negative pregnancy test required of fertile women Adequate contraception required of fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Corticosteroids allowed if dose fixed or decreasing for at least 1 week prior to baseline scan Radiotherapy: No prior radiotherapy Surgery: Not specified
Treatment and study plan
Cyclophosphamide
DrugCytarabine
DrugDexamethasone
DrugDoxorubicin hydrochloride
Drugmethotrexate
Drugvincristine sulfate
Druglow-LET cobalt-60 gamma ray therapy
Radiationlow-LET photon therapy
RadiationPrimary outcomes
-
Response rate
Time frame: Up to 10 years
Secondary outcomes
-
Overall survival
Time frame: Up to 10 years
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
PHASE II TRIAL OF CHEMOTHERAPY PLUS RADIOTHERAPY FOR MANAGEMENT OF PRIMARY CENTRAL NERVOUS SYSTEM NON-HODGKIN'S LYMPHOMA (PCNSL)
Important dates
- Study start
- 1995
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Jun 10, 2004
- Registry last updated
- Jul 14, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression
NCT03480360
Acute Myeloid Leukemia, Anemia
Lebanon, New Hampshire, United States
View Trial DetailsProteomic-Based Profiling of Lymphomas: Chromatin Proteomics; Composition and Modification of Histone and Non-Histone Chromosomal Proteins
NCT01563874
Hemic and Lymphatic Diseases, Immune System Diseases
Bethesda, Maryland, United States
View Trial DetailsA Study of Brentuximab Vedotin in Adults With CD30-positive Lymphoma
NCT04837222
Hemic and Lymphatic Diseases, Immune System Diseases
Hefei, Anhui, China
View Trial DetailsPilot Study of an NTproBNP Guided Strategy of Cardioprotection
NCT04737265
Breast Cancer, Breast Diseases
Duarte, California, United States
View Trial Details