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Randomized Phase II Study of Dose-Adjusted EPOCH vs. NHL-15 Chemotherapy for Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma (NHL)


Phase 2
N/A
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Randomized Phase II Study of Dose-Adjusted EPOCH vs. NHL-15 Chemotherapy for Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma (NHL)


OBJECTIVES: I. Determine the response rates in patients with previously untreated aggressive
non-Hodgkin's lymphoma treated with doxorubicin, etoposide, vincristine, cyclophosphamide,
and prednisone (EPOCH). II. Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive doxorubicin IV, etoposide IV,
vincristine IV, and cyclophosphamide IV continuously over days 1-4. Patients also receive
oral prednisone twice daily on days 1-5 and filgrastim (G-CSF) subcutaneously beginning on
day 6 until blood counts recover. Treatment continues every 21 days for a maximum of 8
courses in the absence of disease progression or unacceptable toxicity. Patients are
followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 59 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage II, III, or IV non-Hodgkin's
lymphoma (NHL) Diffuse large B-cell lymphoma (including immunoblastic features) OR
Anaplastic large cell lymphoma No mantle cell lymphomas including equivocal B-cell
lymphomas that are CD5+ and CD23-, have t(11;14), or express markers of mantle cell
lymphoma or other subtypes No low-grade lymphoma (e.g., follicular center cells in bone
marrow) Patients who have 3-5 International Prognostic Index risk factors must have
refused participation in SWOG-S9704/CALGB-59903 trial No known lymphomatous CNS
involvement, including parenchymal or leptomeningeal involvement

PATIENT CHARACTERISTICS: Age: Not specified Performance status: 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3* Platelet count at
least 100,000/mm3* *unless attributable to NHL Hepatic: Bilirubin no greater than 2.0
mg/dL (without Gilbert's disease)* *unless attributable to NHL Renal: Creatinine no
greater than 1.5 mg/dL* *unless attributable to NHL Cardiovascular: LVEF greater than 45%
No ischemic heart disease No myocardial infarction or congestive heart failure in past
year Other: Not pregnant or nursing Fertile patients must use effective contraception HIV
negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic
chemotherapy No other concurrent chemotherapy Endocrine therapy: Prior glucocorticoids
allowed (less than 10 day course) for urgent local disease at diagnosis (e.g., cord
compression, superior vena cava syndrome) No concurrent dexamethasone (except as indicated
by protocol) or other steroidal antiemetics No concurrent hormonal therapy except for
non-disease related conditions Radiotherapy: Prior limited field radiotherapy allowed
Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Andrew D. Zelenetz, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067947

NCT ID:

NCT00005964

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Lombardi Cancer CenterWashington, District of Columbia  20007
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
CCOP - Southwestern Vermont Regional Cancer CenterBennington, Vermont  05201
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705