S0410 Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: carmustine; cyclophosphamide; etoposide; melphalan; autologous-autologous tandem hematopoietic stem cell transplantation; radiation therapy
Intervention description: 150 mg/m^2 IV over 2 hours 4, 5, and 6 days before transplant.; 100 mg/kg IV 2 days before transplant.; 60 mg/kg IV over 4 hours 4 days before transplant.; 150 mg/m^2 IV 1 day before transplant.; 2.0 x 10^6 CD34+ cells, beginning at least 24 hours after melphalan infusion.; 150 centigray (cGy) total body irradiation given b.i.d on days 5-8 before transplant.
Intervention MeSH terms: Cyclophosphamide; Melphalan; Carmustine; Etoposide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 15 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: recurrent adult Hodgkin lymphoma

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. 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 chemotherapy with a peripheral stem cell
      transplant may allow more chemotherapy to be given so that more cancer cells are killed.
      Tandem (two) autologous stem cell transplants may be an effective treatment for Hodgkin's
      lymphoma.

      PURPOSE: This phase II trial is studying how well tandem stem cell transplantation works in
      treating patients with progressive or recurrent Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed Hodgkin's lymphoma

               -  Relapsed or refractory disease

               -  Biopsy or radiological evidence of disease at time of recurrence/progression
                  required

          -  Has received ≥ 1 prior systemic chemotherapy regimen

          -  No clonal abnormalities in marrow collection

          -  Must undergo involved-field radiotherapy if bulky disease > 5 cm

          -  Must have adequate sections of original diagnostic specimen available for review

               -  Needle aspirations or cytologies are not adequate

          -  No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free > 5
             years)

          -  Patients who relapse after achieving a complete remission must complete a minimum of 2
             courses of salvage chemotherapy or radiation therapy to determine if sensitive or
             resistant recurrent disease is present

          -  No central nervous system (CNS) involvement

        PATIENT CHARACTERISTICS:

        Age

          -  15 to 70

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Hodgkin's disease)

        Renal

          -  Creatinine clearance ≥ 60 mL/min

          -  Creatinine ≤ 2 times upper limit of normal

        Cardiovascular

          -  None of the following conditions requiring therapy:

               -  Coronary artery disease

               -  Cardiomyopathy

               -  Congestive heart failure

               -  Arrhythmias

          -  Ejection fraction ≥ 45% by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram

        Pulmonary

          -  Adequate pulmonary function

          -  Corrected diffusing capacity of lung for carbon monoxide (DLCO) ≥ 60% OR

          -  Forced Expiratory Volume in One Side (FEV_1) ≥ 60% of predicted

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer

          -  No known HIV or AIDS infection

          -  No active bacterial, fungal, or viral infection

          -  No medical condition that would preclude study treatment

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  See Disease Characteristics

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

        Surgery

          -  Not specified