Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment

Not Applicable

Completed

Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome (MDS)
Hodgkins Lymphoma
Non-Hodgkins Lymphoma

Brief Summary: By doing this study, researchers hope to learn the following:

* If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC) transplant will help to improve the homing process

* The safety of HBO administration in the setting of the UBC transplant

* The effects of HBO therapy on the engraftment process

Detailed Description: Research has suggested that high levels of erythropoietin (EPO) decreases the ability of infused umbilical cord stem cells to home to the bone marrow. The investigators will investigate the use of hyperbaric oxygen (HBO) therapy to decrease the plasma concentrations of EPO prior to UBC transplant and evaluate the resulting impact on UBC homing.

Recruitment & Eligibility

Inclusion Criteria

Voluntary written informed consent
Subjects must be >/= 17 yrs and </= 70 yrs for non-myeloablative transplant
Subjects must be >/= 17 yrs and </= 55 yrs for myeloablative transplant
Subjects with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS), Hodgkin's Lymphoma (HL) and Non-Hodgkin's Lymphoma (NHL) who are considered for UCB transplant
Use of approved form of contraception
Karnofsky performance status of >/= 70%
Adequate hepatic, renal, pulmonary and cardiac function. Criteria include:
ALT (alanine aminotransferase), AST (aspartate aminotransferase: < 4x IULN (institutional upper limit of normal)
Total bilirubin </= 2 mg/dL
Serum creatinine < 2.0 mg/dL
Left ventricular ejection fraction >/= 45%
FEV1 (forced expiratory volume), FVC (forced vital capacity) and DLCD (diffusing capacity of lung for carbon monoxide) >/= 50% of predicted value (corrected to serum hemoglobin)

Exclusion Criteria

Pregnancy or breast feeding
Severe chronic obstructive pulmonary disease requiring oxygen supplementation
History of spontaneous pneumothorax
History of seizures
Claustrophobia
Asthma
Uncontrolled viral or bacterial infection at the time of enrollment
Active or recent (prior 6 months) invasive fungal infection without interdisciplinary consult and approval

Arm && Interventions

Group	Intervention	Description
Hyperbaric Oxygen Treatment	Administration of hyperbaric oxygen	Administration of hyperbaric oxygen the morning of UCB transplant.

Primary Outcome Measures

Name	Time	Method
Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation	Toxicity assessment with 24hrs of treatment	Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be related to HBO therapy.

Secondary Outcome Measures

Name	Time	Method
Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.	28 days	Complete engraftment is defined as as marrow reconstitution of greater than 90% of donor cells. Degree of engraftment will be determined through bone marrow chimerism assessment at either day 21 or day 28.
Determine the Effects of HBO Therapy on Neutrophil Count Recovery.	Daily measurement of neutrophil counts up to 90 days post transplant.	Time in days until neutrophil count recovery is achieved; neutrophil count recovery is defined as three consecutive days of achieving a neutrophil level \>/= 500 u/L.