Intensity-Modulated Radiation Therapy, Etoposide, and Cyclophosphamide Followed By Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia
Eligibility Criteria
Inclusion Criteria:
- Patients with acute lymphocytic leukemia or acute myelogenous leukemia who are not in first or second remission (i.e., after failing remission induction therapy or in relapse or beyond second remission)
- All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, DR) identical sibling who is willing to donate bone marrow or primed blood stem cells or a 10/10 allele matched unrelated donor; a single allele mismatch at A, B, C, DR, or DQ and a KIR mismatch at C will be allowed; all ABO blood group combinations of the donor/recipient are acceptable since even major ABO compatibilities can be dealt with by various techniques
- Prior therapy with VP-16, Busulfan, and Cytoxan is allowed
- A cardiac evaluation with an electrocardiogram showing no ischemic changes or abnormal rhythm and an ejection fraction of >= 50% established by multi gated acquisition scan (MUGA) or echocardiogram
- Patients must have a serum creatinine of less than or equal to 1.2 or creatinine clearance > 80 ml/min
- A bilirubin of less than or equal to 1.5
- Serum glutamic oxaloacetic transaminase (SGOT) less than 5 times the upper limit of normal
- Serum glutamate pyruvate transaminase (SGPT) less than 5 times the upper limit of normal
- Pulmonary functioning tests including diffusing capacity of carbon monoxide (DLCO) will be performed; forced expiratory volume in one second (FEV1) and DLCO should be greater than 50% of the predicted normal value
- The time from the end last induction or reinduction attempt should be >= 14 days
- Signed informed consent form approved by the Institutional Review Board (IRB) is required
DONOR: Any sibling donors who are histocompatible with the prospective recipient will be considered a suitable donor
- Donors will be excluded if for psychological or medical reasons they are unable to tolerate the procedure
- Donor should be able to donate peripheral blood stem cells or bone marrow
Exclusion Criteria:
- Prior radiation therapy that would exclude the use of total-body irradiation
- Patients who have undergone bone marrow transplantation previously and who have relapsed
- Patients with psychological or medical condition that patients physician deems unacceptable to proceed to allogeneic bone marrow transplant
- Pregnancy
- Electrocardiogram (EKG) showing ischemic changes or abnormal rhythm and/or an echocardiogram or MUGA scan showing abnormal wall motion or ejection fraction < 50%
Sites / Locations
- City of Hope Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Level 1: 1200cGy
Level 2: 1350cGy
Level 3: 1500cGy limited dose to ribs, sternum, liver, brain 1200cGy
Level 4: 1500cGy limited dose to liver, brain 1200cGy
Level 5: 1600cGy limited dose to liver, porta-hepatic, brain 1200cGy
Level 6: 1700cGy limited dose to liver, porta-hepatic, brain 1200cGy
Level 7: 1800cGy limited dose to liver, porta-hepatic, brain 1200cGy
Level 8: 1900cGy limited dose to liver, porta-hepatic, brain 1200cGy
Level 9: 2000cGy limited dose to liver, porta-hepatic, brain 1200cGy
150cGy BID x Days 1-4. Total dose 1200cGy.
150cGy BID Day 1-4 then 150 cGy QD Day 5. Total dose 1350cGy.
150cGy BID Day 1-5. Total dose 1500Gy.
150cGy BID Day 1-5. Total dose 1500Gy.
160cGy BID Day 1-5. Total dose 1600Gy.
170cGy BID Day 1-5. Total dose 1700Gy.
180cGy BID Day 1-5. Total dose 1800Gy.
190cGy BID Day 1-5. Total dose 1900Gy.
200cGy BID Day 1-5. Total dose 2000Gy.