Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease

• Status: No longer available
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil before the transplant may stop this from happening.

PURPOSE: This clinical trial is studying how well umbilical cord blood stem cell transplant works in treating patients with hematologic cancer or other disease.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Cytarabine; Fludarabine; Fludarabine phosphate; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of 1 of the following:

• Acute myeloid leukemia meeting the following criteria:

• M0-M7 histologic subtypes by French-American-British classification

• Previously treated disease

• Meets 1 of the following criteria:

• Persistent disease as evidenced by 5-30% persistent blasts in bone marrow after induction or salvage therapy

• In second or subsequent complete remission (CR)

• In first CR with 1 of the following high-risk features:

• Philadelphia chromosome present

• Noncore-binding factor type of chromosomal abnormalities

• Myelodysplastic syndromes with 1 of the following International Prognostic Scoring System (IPSS) scores:

• Intermediate-1

• Intermediate-2

• High-risk score with transfusion dependence

• Chronic myelogenous leukemia meeting 1 of the following criteria:

• In accelerated or blastic phase

• Failed prior imatinib mesylate therapy

• Acute lymphoblastic leukemia meeting 1 of the following criteria:

• In first CR with any of the following high-risk features:

• Philadelphia chromosome present

• Translocation t(4;11) present

• WBC > 30,000/mm³ (adult patients)

• More than 4 weeks from initiation of treatment was required to achieve CR (adult patients)

• DNA index of near haploid (N=23 chromosomes) (pediatric patients)

• In second or subsequent CR

• Persistent disease as evidenced by 5-20% persistent blasts in bone marrow after induction or salvage therapy

• Hodgkin's or non-Hodgkin's lymphoma meeting the following criteria:

• Recurrent or refractory disease

• Tumor ≤ 5 cm in diameter

• Myeloma or plasma cell neoplasm meeting 1 of the following staging criteria:

• Stage III at presentation

• Stage I-II at presentation

• Not responding OR progressed after first-line therapy

• Chronic lymphocytic leukemia or Waldenstrom's macroglobulinemia with refractory or progressive disease after first-line therapy

• No 5-6/6 HLA-matched related or 7-8/8 HLA-matched unrelated marrow or peripheral blood stem cell donor available

• No single 4-6/6 HLA-A, -B, or -DRB1-matched umbilical cord blood unit ≥ 3.5 x 10^7 nucleated cells/kg available

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 OR Karnofsky or Lansky PS 70-100%

• Not pregnant

• Fertile patients must use effective contraception prior to and during study participation

• HIV negative

• Bilirubin < 3.0 mg/dL

• AST and ALT ≤ 3 times upper limit of normal

• Creatinine < 2.0 mg/dL OR creatinine clearance > 50 mL/min

• Cardiac ejection fraction > 50% by echocardiogram OR shortening fraction > 27%

• No uncontrolled symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• FEV_1 > 50% of normal

• Forced vital capacity > 50% of normal

• DLCO normal

• Oxygen saturation > 92% on room air (for patients < 5 years of age)

• No history of allergic reactions attributed to compounds of similar chemical or biological composition to busulfan and fludarabine phosphate

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study compliance

• No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 4 weeks since prior and no concurrent surgery

• At least 4 weeks since prior and no other concurrent investigational or commercial agents or therapies for the malignancy, including chemotherapy, biologic therapy, or radiotherapy