A Phase II Study of Umbilical Cord Blood Transplantation
Condition: Leukemia; Lymphoma; Multiple Myeloma; Aplastic Anemia
MeSH terms: Multiple Myeloma; Anemia, Aplastic
Intervention: Umbilical Cord Blood After Myeloablative Conditioning; Umbilical Cord Blood After Reduced-Intensity Conditioning
Intervention description: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0.; Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0.
Intervention MeSH terms: Cyclophosphamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Umbilical cord blood transplantation; full ablation conditioning; reduced intensity conditioning

Summary:

      This study is designed to determine whether Umbilical Cord Transplantation (UCB) can be
      substituted for adult bone marrow cells in the standard stem cell transplant regimens used at
      this hospital for subjects who do not have stem cell donors.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients meeting eligibility criteria for unrelated allogeneic stem cell transplantation
        may be considered for participation on this clinical trial if and only if they meet each of
        the following criteria:

          -  Patients must have one of the following diagnoses

          -  Relapsed or refractory hematologic malignancy, or

          -  High risk hematologic malignancy in first remission, or

          -  Refractory acquired marrow failure state, or

          -  Inherited disorder of metabolism or marrow failure state without alternative curative
             therapy.

          -  Patients must not have a 6/6 or 5/6 HLA-matched related donor.

          -  Patients must not have a HLA-A, -B and -DRB1 high resolution matched unrelated donor
             following registry search, or cannot (in the opinion of the treating physician) wait
             the median 3 months to receive a MUD unit.

          -  Patients must demonstrate an ability to understand and willingness to sign the
             informed consent document

        Patients considered for myeloablative conditioning must satisfy the following additional
        criteria:

          -  Patients must be up to age 55 (inclusive)

          -  Patients must have serum direct bilirubin ≤ 2.0 mg/dl and transaminases ≤ 2x
             institution upper limit of normal

          -  Patients must have serum creatinine ≤ 2 mg/dl with creatinine clearance ≥ 60 ml/min
             (either calculated or measured).

          -  Patients must have MUGA scan or echocardiogram normal for the institution, but not
             less than 45% left ventricular ejection fraction and no clinical evidence of cardiac
             dysfunction.

          -  Patients must have an ECOG performance status of 0 or 1 (see Appendix C).

          -  Patients must have adequate pulmonary function when corrected for hemoglobin and
             alveolar volume as evidenced by a diffusion capacity and FEV1 > 50% of predicted.

        Patients considered for reduced-intensity conditioning must satisfy the following
        additional criteria:

          -  Patients must not be candidates for myeloablative conditioning due to any one of the
             following: Prior myeloablative stem cell transplantation, Age > 50, Co morbid illness

          -  In opinion of treating physician, unable to comply with or withstand rigors of
             myeloablative conditioning

          -  Patients with leukemia must have circulating and bone marrow blast counts < 5%, all
             other patients must have chemotherapy responsive disease

          -  Patients must be between the ages of 18 and 70 (inclusive)

          -  Patients must have serum direct bilirubin ≤ 2.0 mg/dL and transaminases ≤ 3x
             institution upper limit of normal

          -  Patients must have creatinine clearance ≥ 30 ml/min (either calculated or measured).

          -  Patients must have MUGA scan or echocardiogram documenting left ventricular ejection
             fraction of no less than 35% and no clinical evidence of cardiac dysfunction.

        Patients must have an ECOG performance status of 0 or 1 (see Appendix C).

        Patients must have adequate pulmonary function when corrected for hemoglobin and alveolar
        volume as evidenced by a diffusion capacity and FEV1 ≥ 40% of predicted.

        Exclusion Criteria:

        Patients are ineligible for participation on this trial if they meet any of the following
        criteria:

          -  Patients with a history of myocardial infarction within the preceding 6 months,
             significant arrhythmia within the preceding 3 months, uncontrolled hypertension or
             congestive heart failure are ineligible.

          -  Patients with unstable angina are not eligible.

          -  Pregnant or lactating women are ineligible.

          -  Male and female patients who do not agree to practice approved methods of birth
             control for the duration of the study are ineligible.

          -  Patients with uncontrolled infection are ineligible.

          -  Patients who are HIV positive or have evidence of chronic viral hepatitis are
             ineligible.

          -  Patients unable to comply with requirements for compliance with therapeutic plan
             and/or scheduled evaluations