Clinical trial NCT00005090 (phase 3, status: terminated)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: carmustine, cyclophosphamide, dacarbazine, doxorubicin hydrochloride, etoposide, vinblastine
SMILES: ClCCNC(=O)N(CCCl)N=O, ClCCN(CCCl)P1(=O)NCCCO1, N1C=CN=C1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, N[C@@H](CCCNC(N)=N)C(O)=O
Reason stopped: 
    poor accrual
  
Eligibility 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)