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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00002676

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

135

Duration (Months)

1.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	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	Phase 2

Detailed Description

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).

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 1995

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CHOD + BVAM + WBRT 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 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

Arm

Intervention/Treatment

Experimental: CHOD + BVAM + WBRT

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

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

Outcome Measures

Primary Outcome Measures

Response rate [Up to 10 years]

Secondary Outcome Measures

Overall survival [Up to 10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	CCOP - Colorado Cancer Research Program, Inc.	Denver	Colorado	United States	80209-5031
3	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
4	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
5	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
6	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
7	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
8	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
9	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
10	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
11	CCOP - Duluth	Duluth	Minnesota	United States	55805
12	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
13	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
14	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68131
15	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
16	Quain & Ramstad Clinic, P.C.	Bismarck	North Dakota	United States	58501
17	Altru Health Systems	Grand Forks	North Dakota	United States	58201
18	CCOP - Columbus	Columbus	Ohio	United States	43206
19	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
20	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
21	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57105-1080