Chemotherapy and Whole-Brain Radiation Therapy in Treating Patients With Primary Central Nervous System Non- Hodgkin's Lymphoma - Article
Clinical Trial: Chemotherapy and Whole-Brain Radiation Therapy in Treating Patients With Primary Central Nervous System Non- Hodgkin's Lymphoma
This study is no longer recruiting patients.
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.
|Condition||Treatment or Intervention||Phase|
|primary central nervous system lymphoma || Drug: carmustine |
Drug: leucovorin calcium
|Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lymphoma; Neurologic Diseases
Study Type: Interventional
Study Design: Treatment
Study start: June 1996
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.
PROTOCOL OUTLINE: The following acronyms are used: ARA-C Cytarabine, NSC-63878 BCNU Carmustine, NSC-409962 BVAM BCNU/VCR/ARA-C/MTX CF Leucovorin calcium, NSC-3590 CHOD CTX/DOX/VCR/DM CTX Cyclophosphamide, NSC-26271 DM Dexamethasone, NSC-34521 DOX Doxorubicin, NSC-123127 MTX Methotrexate, NSC-740 VCR Vincristine, NSC-67574 WBRT Whole-Brain Radiotherapy
4-Drug Combination Chemotherapy followed by 4-Drug Combination Chemotherapy followed by Radiotherapy. CHOD; followed by BVAM; followed by WBRT using 4-6 MV equipment (10 MV or greater allowed with proper documentation).
PROJECTED ACCRUAL: Up to 35 patients will be entered over approximately 4.5 years. The study will close early if there is an unacceptable incidence of severe toxicity or treatment failure.
Ages Eligible for Study: 18 Years - 70 Years
PROTOCOL ENTRY CRITERIA:
- 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
- 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
- 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
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, 85259-5404, United States
CCOP - Colorado Cancer Research Program, Inc., Denver, Colorado, 80209-5031, United States
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61602, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, 52403-1206, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States
Siouxland Hematology-Oncology, Sioux City, Iowa, 51101-1733, United States
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States
CCOP - Ochsner, New Orleans, Louisiana, 70121, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States
CCOP - Duluth, Duluth, Minnesota, 55805, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68131, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, 07601, United States
Altru Health Systems, Grand Forks, North Dakota, 58201, United States
Quain & Ramstad Clinic, P.C., Bismarck, North Dakota, 58501, United States
CCOP - Columbus, Columbus, Ohio, 43206, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, 43623-3456, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, 57105-1080, United States
Rapid City Regional Hospital, Rapid City, South Dakota, 57709, United States
Brian Patrick O'Neill, Study Chair, North Central Cancer Treatment Group
Mark R. Gilbert, Study Chair
Record last reviewed: June 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002676
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005
- Central Nervous System Lymphoma, Primary (National Cancer Institute)