High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors
High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors
This pilot trial studies different high-dose chemotherapy regimens with or without total-body
 irradiation (TBI) to compare how well they work when given before autologous stem cell
 transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Giving
 high-dose chemotherapy with or without TBI before ASCT stops the growth of cancer cells by
 stopping them from dividing or killing them. After treatment, stem cells are collected from
 the patient's blood or bone marrow and stored. More chemotherapy may be given to prepare for
 the stem cell transplant. The stem cells are then returned to the patient to replace the
 blood forming cells that were destroyed by the chemotherapy.
PRIMARY OBJECTIVES:

 I. Estimate the progression free survival (PFS) distribution for Hodgkin lymphoma (HL),
 non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) for each disease-specific high dose
 therapy regimen.

 SECONDARY OBJECTIVES:

 I. Estimate the PFS distribution for amyloidosis, acute leukemia and selected solid tumors
 for each disease-specific high dose therapy regimen.

 II. Explore the role of risk factors in the outcome of all treated patients. III. Examine the
 high dose therapy regimen-related toxicity (RRT) and overall survival after bone marrow
 transplant (BMT).

 OUTLINE:

 Patients are assigned to conditioning regimens based on disease, age, and co-morbidities.
Inclusion Criteria:

 -  Histologically confirmed diagnosis of malignant hematologic disorders, amyloidosis or
 solid tumor malignancy

 -  Recurrent or refractory disease or disease at high risk for recurrence

 -  Hodgkin Disease (HL): Relapsed or refractory disease after chemotherapy with a minimum
 of one standard regimen

 -  Non-Hodgkin Lymphoma (NHL): (Low, Intermediate or High Grade) Relapsed or refractory
 disease after chemotherapy with at least one standard regimen or first complete
 remission (CR) lymphoblastic or small, non-cleaved cell lymphoma at high risk of
 relapse by high International Prognostic Index (IPI) Score

 -  Acute Myeloid Leukemia (AML): Low or High Risk disease in first or second CR or
 greater in patients in whom the risks of an allogeneic transplant outweigh the
 benefits

 -  Acute Lymphoblastic Leukemia (ALL): Low or high risk disease in first or second CR in
 whom the risks of an allogeneic transplant outweigh the benefits

 -  Multiple Myeloma (MM): Low or high risk in first or greater response (stable disease
 or better) or for responding patients at first progression

 -  Other Malignant Lymphoproliferative Disorders: (chronic lymphocytic lymphoma [CLL],
 Waldenstroms macroglobulinemia, relapsed or refractory disease after first-line
 chemotherapy

 -  Amyloidosis: primary or previously treated

 -  Solid Tumors: Testicular cancer patients who have relapsed disease or primary
 progressive disease which is responding to salvage therapy; relapsed or advanced-stage
 newly diagnosed neuroblastoma (NBL) or small round blue cell tumors (SRBCT) in
 patients 30 years of age; other patients with solid tumors who have recurred following
 conventional treatment or are at high risk for relapse, and demonstrate
 chemosensitivity

 -  Patients with malignancies who would be treated with an autologous stem cell
 transplant but have a syngeneic donor; a syngeneic donor would be considered to have
 the same risk as an autologous stem cell transplant patient

 -  Performance status 0-2 (Karnofsky performance status [KPS] >= 70%); patients with
 amyloidosis or MM with decreased KPS due to disease are eligible

 -  Life expectancy > 2 months

 -  Pulmonary function tests; diffusing capacity of the lung for carbon monoxide (DLCO) or
 diffusing volume of the alveolar volume (DLVA) >= 50% predicted; DLCO to be corrected
 for hemoglobin and/or alveolar ventilation

 -  Cardiac ventricular ejection fraction >= 50% by radionuclide ventriculogram or
 echocardiogram

 -  Bilirubin < 3 x normal

 -  Alkaline phosphatase, serum glutamic oxaloacetic transaminase (SGOT) < 3 x normal

 -  Calculated creatinine clearance < 40 cc/min by the modified Cockcroft-Gault formula
 for adults or the Schwartz formula for pediatrics

 -  Glomerular filtration rate by renal scan for neuroblastoma patients, to determine
 dosing parameters

 -  Positive cytomegalovirus (CMV) immunoglobulin M (IgM) and/or positive hepatitis
 serologies demonstrating infection will require an Infectious Disease consult and
 subsequent clearance

 -  Any active infection will require an Infectious Disease consult and subsequent
 clearance

 -  Peripheral Blood Counts of polymorphonuclear neutrophil (PMN) > 1500/uL

 -  Platelet (Plt) > 75,000/uL

 -  Prior to stem cell storage:

 -  No radiation within three weeks before stem cell harvest

 -  Bone marrow may be used in conjunction with blood progenitor cells

 -  Hematologic Malignancy patients with human immunodeficiency virus (HIV) positivity but
 on appropriate anti-retroviral therapy may go autotransplant with the following
 laboratory tests; (CD4+ cell count > 75 cells per microliter and HIV copy number <
 100,000 per microliter and with Infectious Disease clearance

 -  Acute Leukemia, HL, NHL, MM and Solid Tumor patients must have received 2 cycles of
 chemotherapy followed by disease-specific restaging prior to mobilization and
 collection of stem cells; small round blue cell tumor patients must have received
 either standard therapy or surgical intervention; the disease status and response to
 therapy must be known prior to transplant to establish the disease status at
 transplant; amyloidosis patients may proceed to BMT without receiving chemotherapy

 -  No serious organ dysfunction unless it is caused by the underlying disease, exclusion
 criteria include the following:

 -  Uncontrolled or severe cardiovascular disease, including recent (< 6 months)
 myocardial infarction, congestive heart failure, symptomatic angina,
 life-threatening arrhythmia or hypertension

 -  Active bacterial, viral, or fungal infection

 -  Active peptic ulcer disease

 -  Uncontrolled diabetes mellitus

 -  No serious medical or psychiatric illness

 -  Not pregnant

 -  No psychiatric conditions which would prevent delivery of care; psychology clearance
 is necessary

 -  Allogeneic BMT not possible, or not desirable

 -  Age > 65 years

 -  No compatible donor identified

 -  Estimated risk of graft vs. host disease complications greater than risk of
 recurrence after autologous BMT

 -  Adequate bone marrow or blood stem cell dose obtained:

 -  For blood stem cells: total CD 34+ >= 2 x 10^6/kg or if unable to collect this
 dose, a total nucleated cell bone marrow dose of >= l x 10^8/kg