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.

Sponsors and Collaborators: National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
primary central nervous system lymphoma
 Drug: carmustine
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: dexamethasone
 Drug: doxorubicin
 Drug: leucovorin calcium
 Drug: methotrexate
 Drug: vincristine
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphoma;   Neurologic Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Sequential CHOD (CTX/DOX/VCR/DM), BVAM (BCNU/VCR/ARA-C/MTX), and Whole-Brain Radiotherapy for Primary Central Nervous System non-Hodgkin's Lymphoma

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

--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

Location Information


Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States

Colorado
      CCOP - Colorado Cancer Research Program, Inc., Denver,  Colorado,  80209-5031,  United States

Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States

      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States

Iowa
      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

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States

Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States

Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States

Minnesota
      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

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States

New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States

North Dakota
      Altru Health Systems, Grand Forks,  North Dakota,  58201,  United States

      Quain & Ramstad Clinic, P.C., Bismarck,  North Dakota,  58501,  United States

Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States

      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States

South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57105-1080,  United States

      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States

Study chairs or principal investigators

Brian Patrick O'Neill,  Study Chair,  North Central Cancer Treatment Group   
Mark R. Gilbert,  Study Chair

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000064319; NCCTG-937351; E-N9371
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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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