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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Brian P. O'Neill, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000064319

NCT ID:

NCT00002676

Start Date:

July 1995

Completion Date:

Related Keywords:

  • Lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado  80209-5031
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - ColumbusColumbus, Ohio  43206