Chemotherapy and Whole-Brain Radiation Therapy in Treating Patients With Primary Central Nervous System Non- Hodgkin's Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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PHASE II TRIAL OF CHEMOTHERAPY PLUS RADIOTHERAPY FOR MANAGEMENT OF PRIMARY CENTRAL NERVOUS SYSTEM NON-HODGKIN'S LYMPHOMA (PCNSL)

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: carmustine
* Drug: cyclophosphamide
* Drug: cytarabine
* Drug: dexamethasone
* Drug: doxorubicin hydrochloride
* Drug: methotrexate
* Drug: vincristine sulfate
* Radiation: low-LET cobalt-60 gamma ray therapy
* Radiation: low-LET photon therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHOD + BVAM + WBRT<br>Patients 70 years old and younger with newly diagnosed, biopsy-proven PCNSL received one cycle of CHOD followed by two cycles of BVAM. Patients then received WBRT, 30.6 Gy, if a complete response was evoked, or 50.4 Gy if the response was less than complete; both doses were given in 1.8-Gy daily fractions. | Drug: carmustine<br> <br> Drug: cyclophosphamide<br> <br> Drug: cytarabine<br> <br> Drug: dexamethasone<br> <br> Drug: doxorubicin hydrochloride<br> <br> Drug: methotrexate<br> <br> Drug: vincristine sulfate<br> <br> Radiation: low-LET cobalt-60 gamma ray therapy<br> <br> Radiation: low-LET photon therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary central nervous system non-Hodgkin lymphoma