Busulfan, Melphalan, and Thiotepa in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Hodgkin's or Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: filgrastim; busulfan; melphalan; thiotepa; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation
Intervention description: 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days.; 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.; 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.; 250 mg/m2/day/iv on days -3 and -2; The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.; Performed 36-48 hours following last chemotherapy dose.
Intervention MeSH terms: Melphalan; Busulfan; Thiotepa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Maximum age: 70 Years
Healthy volunteers: No
Keywords: recurrent adult Hodgkin lymphoma; recurrent adult diffuse small cleaved cell lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; recurrent grade 3 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 3 follicular lymphoma; recurrent adult diffuse mixed cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage IV adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; stage III adult lymphoblastic lymphoma; stage IV adult lymphoblastic lymphoma; recurrent adult Burkitt lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma; recurrent mantle cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; recurrent marginal zone lymphoma; splenic marginal zone lymphoma; recurrent small lymphocytic lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent/refractory childhood Hodgkin lymphoma; stage III childhood Hodgkin lymphoma; stage IV childhood Hodgkin lymphoma; recurrent childhood anaplastic large cell lymphoma; stage III childhood anaplastic large cell lymphoma; stage IV childhood anaplastic large cell lymphoma; childhood grade III lymphomatoid granulomatosis; recurrent childhood large cell lymphoma; stage III childhood large cell lymphoma; stage IV childhood large cell lymphoma; recurrent childhood lymphoblastic lymphoma; stage III childhood lymphoblastic lymphoma; stage IV childhood lymphoblastic lymphoma; recurrent childhood small noncleaved cell lymphoma; stage III childhood small noncleaved cell lymphoma; stage IV childhood small noncleaved cell lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma

Summary:

      RATIONALE: Chemotherapy, such as busulfan, melphalan, and thiotepa, may destroy cancerous
      blood-forming cells (stem cells) in the blood and bone marrow. Giving the patient their
      healthy stem cells will help their bone marrow make new stem cells that become red blood
      cells, white blood cells, and platelets.

      PURPOSE: This phase II trial is studying how well busulfan, melphalan, and thiotepa work in
      treating patients who are undergoing an autologous stem cell transplant for Hodgkin's or
      non-Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of 1 of the following:

               -  Intermediate- or high-grade non-Hodgkin's lymphoma (NHL), meeting 1 of the
                  following criteria:

                    -  In first complete remission (CR) AND at high-risk for relapse, as defined by
                       all of the following criteria:

                         -  High age-adjusted International Prognostic Index category AND meets the
                            following criteria at diagnosis:

                              -  Stage III or IV disease

                              -  Lactic dehydrogenase abnormal

                              -  Eastern Cooperative Oncology Group (ECOG) score 0-2

                         -  Mantle cell histology

                    -  Primary refractory disease

                    -  Beyond first CR

               -  Low-grade NHL

                    -  Beyond second relapse

               -  Hodgkin's lymphoma

                    -  Primary refractory disease OR beyond first CR

          -  Must have an adequate number of stored autologous peripheral blood stem cells (PBSCs)
             (i.e., 2.0 x 10^6 hematopoietic progenitor cell antigen (CD34)-positive cells/kg)

               -  Patients who are not able to mobilize a sufficient number of PBSCs may use bone
                  marrow instead

          -  No active CNS disease NOTE: A new classification scheme for adult non-Hodgkin's
             lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive"
             lymphoma will replace the former terminology of "low", "intermediate", or "high" grade
             lymphoma. However, this protocol uses the former terminology.

        PATIENT CHARACTERISTICS:

        Age

          -  0 to 70

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  Bilirubin < 2 times upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times ULN

        Renal

          -  Creatinine ≤ 2.0 mg/dL

          -  Creatinine clearance ≥ 50 mL/min

        Pulmonary

          -  No significant pulmonary dysfunction, defined as Diffusing Capacity the Lung for
             Carbon monoxide (DLCO) < 60% of predicted

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception for ≥ 2 months before and during
             study participation

          -  HIV negative

          -  No significant active infection that would preclude PBSC transplantation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior transplantation

          -  No other concurrent blood products during PBSC transplantation

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  More than 60 days since prior local or regional radiotherapy

        Surgery

          -  Not specified

        Other

          -  More than 30 days since prior investigational drugs

          -  No concurrent amphotericin