Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: filgrastim; busulfan; cyclophosphamide; etoposide; melphalan; autologous-autologous tandem hematopoietic stem cell transplantation; radiation therapy
Intervention description: 480 mcg beginning day +5; 11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses; 60 mg/kg IV over 2 hours x 2 days; 60 mg/kg, IV; 150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes.; autologous-autologous tandem hematopoietic stem cell transplantation; radiation therapy
Intervention MeSH terms: Cyclophosphamide; Melphalan; Busulfan; Etoposide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma

Summary:

      RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an
      effective treatment for Hodgkin's lymphoma.

      PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants
      works in treating patients with progressive or recurrent Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically* confirmed Hodgkin's lymphoma meeting ≥ 1 of the following criteria:

               -  Disease progression during initial first line chemotherapy

               -  Complete response lasting ≤ 90 days after induction

               -  Partial response lasting ≤ 90 days after induction

               -  First recurrence/progression with the duration of initial response ≤ 12 months
                  after completion of chemotherapy NOTE: *There must be unequivocal radiological
                  evidence of recurrent or progressive disease if biopsy was not obtained at time
                  of disease recurrence/progression

          -  No clonal abnormalities in marrow collection

          -  Must have bilateral or unilateral bone marrow aspirates and biopsy within 42 days
             prior to stem cell collection

          -  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)

          -  No CNS involvement

        PATIENT CHARACTERISTICS:

        Performance status

          -  Karnofsky 50-100%

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal* (ULN) NOTE: *Unless due to Hodgkin's
             lymphoma

        Renal

          -  Creatinine clearance ≥ 60 mL/min

          -  Creatinine ≤ 2.0 times ULN

        Cardiovascular

          -  Ejection fraction ≥ 45% by 2-D echocardiogram

          -  No significant active cardiac disease

        Pulmonary

          -  Adequate pulmonary function

          -  DLCO ≥ 45%

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  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:

        Chemotherapy

          -  See Disease Characteristics

        Surgery

          -  See Disease Characteristics