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A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients With Advanced Stage Poor Prognosis Hodgkin's Disease as Defined by the International Prognostic Factors Project on Advanced Hodgkin's Disease


Phase 3
15 Years
65 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients With Advanced Stage Poor Prognosis Hodgkin's Disease as Defined by the International Prognostic Factors Project on Advanced Hodgkin's Disease


OBJECTIVES:

- Compare progression-free and overall survival of patients with stage III or IV
Hodgkin's disease treated with doxorubicin, bleomycin, vinblastine, and dacarbazine
with or without autologous peripheral blood stem cell transplantation and high-dose
chemotherapy.

- Compare the toxic effects of these treatment regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
number of poor prognostic factors (3 vs 4 vs 5) and stage of disease (III vs IV).

Patients receive induction chemotherapy consisting of doxorubicin IV over 5 minutes,
bleomycin IV over 10 minutes, vinblastine IV over 5 minutes, and dacarbazine IV over 15-30
minutes on days 1 and 15. Treatment repeats every 28 days for 5 courses in the absence of
disease progression or unacceptable toxicity. Patients who show at least partial response
after the fifth course of induction chemotherapy and whose blood counts have recovered are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive 3 additional courses of induction chemotherapy for a total of 8
courses.

- Arm II: Patients receive 1 additional course of induction chemotherapy followed by stem
cell collection. Patients then receive high-dose chemotherapy with carmustine IV over 2
hours on days -6 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on
day -2. Patients undergo autologous peripheral blood stem cell transplantation on day
0.

Patients are followed at 60 days, every 3 months for 1 year, every 6 months for 2 years, and
then annually thereafter.

PROJECTED ACCRUAL: Approximately 460 patients will be accrued for this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage III or IV Hodgkin's disease with at least 3 of the
following characteristics:

- Albumin less than 4.0 mg/dL

- Hemoglobin less than 10.5 g/dL

- Leukocytosis at least 15,000/mm^3

- Lymphocytopenia less than 600/mm^3 or less than 8% of total WBC

- Male sex

- At least 45 years of age

- Stage IV disease

- Bidimensionally measurable disease

- Bilateral or unilateral bone marrow aspiration and biopsy performed within 42 days of
study

- Negative chest x-ray within 42 days of study OR

- Chest x-ray performed within 28 days of study

- Negative CT scan of thorax, abdomen, and pelvis within 42 days of study OR

- CT scan of thorax, abdomen, and pelvis performed within 28 days of study

- No history of lymphoma, myelodyplastic syndrome, or leukemia

- No CNS involvement by Hodgkin's disease

PATIENT CHARACTERISTICS:

Age:

- 15 to 65

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

Hepatic:

- See Disease Characteristics

- Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless elevation due
to liver infiltration by Hodgkin's disease)

- Lymphoma-related hepatic dysfunction allowed

Renal:

- Creatinine no greater than 2.0 times ULN

- Creatinine clearance at least 60 mL/min

- Lymphoma-related renal dysfunction allowed

Cardiovascular:

- No coronary artery disease, cardiomyopathy, congestive heart failure, or arrhythmias
requiring therapy

- Ejection fraction normal

- No significant EKG abnormalities suggesting active cardiac disease

Pulmonary:

- Corrected DLCO at least 60% OR

- FEV1 at least 60% predicted

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No HIV or AIDS

- No other prior malignancy within past 5 years except adequately treated basal cell or
squamous cell skin cancer

- No active bacterial, fungal, or viral infection*

- Afebrile for 3 consecutive days* NOTE: *Prior to randomization portion of study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for Hodgkin's disease except single course of ABVD
(doxorubicin, bleomycin, vinblastine, and dacarbazine) within 35 days of study

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy for Hodgkin's disease

Surgery:

- Not specified

Other:

- At least 3 days since prior antibiotics, antifungals, or antivirals (except for
prophylactic therapy or fever associated with underlying lymphoma) (for randomization
portion of study)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter

Safety Issue:

No

Principal Investigator

Ellen R. Gaynor, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Loyola University

Authority:

United States: Federal Government

Study ID:

CDR0000067708

NCT ID:

NCT00005090

Start Date:

April 2000

Completion Date:

May 2005

Related Keywords:

  • Lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

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
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
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
Schneider Children's Hospital at North ShoreManhasset, New York  11030