Combination Chemotherapy With or Without Bortezomib in Treating Patients With Classical Hodgkin Lymphoma That Has Returned or Does Not Respond to Prior Treatment.
Condition: Recurrent Classic Hodgkin Lymphoma; Refractory Classic Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Bortezomib; Carboplatin; Etoposide; Ifosfamide
Intervention description: Given IV; Given IV; Given IV; Given IV
Intervention MeSH terms: Carboplatin; Etoposide; Etoposide phosphate; Bortezomib; Ifosfamide; Isophosphamide mustard; Podophyllotoxin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well combination chemotherapy with or without bortezomib
      works in treating patients with classical Hodgkin lymphoma that has come back or does not
      respond to prior treatment. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and
      etoposide, work in different ways to stop the growth of cancer cells, either by killing the
      cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib is
      designed to block a protein that plays a role in cell function and growth. Bortezomib may
      cause cancer cells to die. It is not yet known if combination chemotherapy with or without
      bortezomib may work better in treating patients with classical Hodgkin lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsed or refractory classical Hodgkin lymphoma.

          -  Patients must have received a front-line standard anthracycline-containing regimen,
             such as adriamycin-bleomycin-vinblastine-dacarbazine (ABVD), Stanford V, or
             bleomycin-etoposide-adriamycin-cyclophosphamide-oncovin-procarbazine-prednisone
             (BEACOPP).

          -  Bi-dimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single
             dimension.

          -  Absolute neutrophil count (ANC) >= 1,500/microL.

          -  Platelet count >= 100,000/ microL.

          -  Hemoglobin >= 8 g/dL.

          -  Serum bilirubin < 2.0 mg/dL.

          -  Alkaline phosphatase < 2 x upper limits of normal (ULN).

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 x ULN.

          -  Serum creatinine =< 1.5 mg/dL.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to
             2.

          -  Females of childbearing potential must have a negative serum beta-human chorionic
             gonadotropin (hCG) pregnancy test and must agree to use 2 highly effective
             contraceptive methods (hormonal contraceptive, intra-uterine device, diaphragm with
             spermicide, condom with spermicide, or abstinence) during the study and for 3 months
             after completion of protocol treatment. Females of non-childbearing potential are
             those who are postmenopausal for greater than 1 year or whom have had a bilateral
             tubal ligation or hysterectomy.

          -  Males who have partners of childbearing potential must agree to use an effective
             contraceptive method during the study and for 3 months after completion of protocol
             treatment.

          -  Voluntary written informed consent before performance of any study-related procedure
             not part of normal medical care, with the understanding that consent may be withdrawn
             by the subject at any time without prejudice to future medical care.

        Exclusion Criteria:

          -  Lymphocyte predominant Hodgkin lymphoma histology.

          -  More than one prior chemotherapy regimen.

          -  Prior autologous or allogeneic stem cell transplant.

          -  Presence of central nervous system (CNS) involvement with Hodgkin lymphoma.

          -  Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency
             syndrome (AIDS).

          -  Active hepatitis B or C infection or history of cirrhosis.

          -  Grade 2 or greater peripheral neuropathy within 14 days of enrollment.

          -  Hypersensitivity to boron or mannitol.

          -  Prior bortezomib therapy.

          -  Another primary malignancy (other than squamous cell and basal cell carcinoma of the
             skin, in situ carcinoma of the cervix, or squamous intraepithelial lesion on PAP
             smear, or treated prostate cancer with a stable prostate specific antigen [PSA]) for
             which the patient has not been disease-free for at least 3 years.

          -  Patients with congestive heart failure, Class III or IV, by New York Heart Association
             (NYHA) criteria.

          -  Patients with a myocardial infarction 6 months prior to enrollment, uncontrolled
             angina, severe uncontrolled ventricular arrhythmias, or electrocardiogram (ECG)
             evidence of acute ischemia or active conduction system abnormalities.

          -  Patient with other medical or psychiatric illness that is likely to interfere with
             participation in this clinical study.

          -  Female subject that is pregnant or breast-feeding.

          -  Patient that has received other investigational drugs within 14 days of enrollment.

          -  Patients using concurrent therapy with corticosteroids at greater than or equal to 20
             mg/day of prednisone equivalent.

          -  Patients with active systemic bacterial, viral, or fungal infections that have
             required IV antimicrobials within 4 weeks prior to protocol treatment.