Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed or Refractory Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: carboplatin; etoposide; ifosfamide
Intervention description: Given IV; Given IV; Given IV
Intervention MeSH terms: Carboplatin; Etoposide; Ifosfamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 72 Years
Healthy volunteers: No
Keywords: adult lymphocyte depletion Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma; recurrent adult Hodgkin lymphoma

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Giving more than one
      drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses
      high-energy x-rays to kill cancer cells. Giving combination chemotherapy and radiation
      therapy with an autologous stem cell transplant, using peripheral stem cells or bone marrow
      from the patient, may allow more chemotherapy to be given so that more cancer cells are
      killed. Giving combination chemotherapy together with radiation therapy before an autologous
      stem cell transplant may be an effective treatment for Hodgkin's lymphoma.

      PURPOSE: This phase II trial is studying how well combination chemotherapy and radiation
      therapy work in treating patients who are undergoing an autologous stem cell transplant for
      relapsed or refractory Hodgkin's lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic diagnosis of Classical Hodgkin's Lymphoma. Lymphocyte predominant histology
             will be excluded.

          -  Primary refractory or relapsed disease proven by biopsy or fine needle aspiration
             (cytology) of an involved site

          -  Failure of doxorubicin or nitrogen mustard containing front-line therapy

          -  18F-fluorodeoxyglucose-PET scan demonstrating PET avid disease

          -  Cardiac ejection fraction of greater than 45%, measured since last chemotherapy.

          -  Adjusted diffusing capacity of greater than 50% on pulmonary function testing,
             measured since last chemotherapy

          -  Serum creatinine < than or = to 1.5 mg/dl; if creatinine >1.5 mg/dl then the measured
             12- or 24-hour creatinine clearance must be >60 ml/minute.

          -  ANC>1000/μl and Platelets>50,000/μl

          -  Total bilirubin < than or = to 2.0 mg/dl in the absence of a history of Gilbert's
             disease.

          -  Females of childbearing age must be on an acceptable form of birth control.

          -  Age between 18 and 72

          -  HIV I and II negative.

          -  Patients or their guardians must be capable of providing informed consent.

        Exclusion Criteria:

        Histology for Lymphocyte predominant subtype Hodgkin's Lymphoma

          -  Prior treatment with carboplatin, cisplatin, ifosfamide, gemcitabine, or vinorelbine

          -  Hepatitis B surface antigen positive.

          -  Known pregnancy or breast-feeding.

          -  Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the
             attending physician and/or principal investigator, will preclude administering
             chemotherapy safely.

          -  History of any malignancy for which the disease-free interval is <5 years, excluding
             curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma
             in-situ of the cervix