High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors
Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
About this trial
This is an interventional treatment trial for Adult Acute Lymphoblastic Leukemia in Remission
Eligibility Criteria
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
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Regimen CBV (patients with HL or NHL)
Regimen M200/M120 (patients with MM or amyloidosis)
Regimen BuC2iv (patients with ALL, AML, HL, or NHL)
Regimen CT6 (patients with ALL)
Regimen CTtCp (patients with other solid tumors)
Regimen VCp (patients with testicular cancer)
Regimen TtC1500/ECpM (patients with NBL or SRBCT)
Patients receive etoposide intravenously (IV) continuously over 34 hours on day -8, cyclophosphamide IV over 2 hours on days -7 to -4, and carmustine IV over 2 hours on day -3. Patients undergo ASCT on day 0.
Patients receive 200 or 120 mg/m^2 of melphalan IV over 30 minutes on day -2. Patients undergo ASCT on day 0.
Patients receive busulfan IV over 2 hours then every 6 hours on days -7 to -4 for 16 total doses and cyclophosphamide IV over 2 hours on days -3 and -2. Patients undergo ASCT on day 0.
Patients receive cyclophosphamide IV over 2 hours on days -5 to -4. Patients then undergo TBI twice daily on days -3 to -1. Patients undergo ASCT on day 0.
Patients receive cyclophosphamide IV continuously, carboplatin IV continuously, and thiotepa IV continuously over 24 hours on days -7 to -4. Patients undergo ASCT on day 0.
Patients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4. Patients undergo ASCT on day 0. At least 4 weeks after the first transplant, patients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4. Patients then undergo a second ASCT on day 0.
Patients receive thiotepa IV over 2 hours on days -7 to -5 and cyclophosphamide IV over 2 hours on days -5 to -2. Patients undergo ASCT on day 0. At least 4 weeks after the first transplant, patients receive carboplatin IV continuously over 24 hours on days -7 to -4, etoposide IV continuously over 24 hours on days -7 to -4, and melphalan IV over 30 minutes on days -7 to -5. Patients undergo a second ASCT on day 0.