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Investigator(s):
Alan Wayne, M.D. Principal Investigator Phone: 301-496-4256 waynea@mail.nih.gov
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)

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Primary Eligibility:

• Diagnosis of one of the following cancers of the blood:
• Acute lymphocytic leukemia (ALL) ≤ 25% marrow blasts
• Acute myelogenous leukemia (AML) ≤ 25% marrow blasts
• Chronic myelogenous leukemia (CML) meeting one of the following criteria:
• Chronic phase or recurrent disease after donor lymphocyte infusion (DLI) or resistant to DLI or resistant to available abl kinase inhibitors
• Accelerated phase < 20% marrow blasts
• Blastic phase ≤ 25% marrow blasts
• Myelodysplastic syndrome (MDS) < 20% marrow blasts
• Non-Hodgkin’s lymphoma meeting both of the following criteria:
• Stage IV disease
• ≤ 25% marrow blasts
• WT-1 expression confirmed by 1 or more of the following:
• At least 15% of malignant cells react with anti-WT-1 by pathology testing
• Molecular testing of malignant cells (positive quantitative RT-PCR)
• HLA-A2 positive (heterozygous expression is acceptable)
• Residual or relapsed disease* after receiving a prior HLA-matched (5 -6/6 antigen or 8-10/10 allele) related or unrelated allogeneic stem cell transplantation
• Must have post-transplant donor engraftment, defined by all of the following:
• Donor chimerism > 50% (peripheral blood)
• ANC > 500/mm³ (independent of myeloid growth factors)
• Platelet count > 20,000/mm³ (independent of transfusion)
  [*Note: Minimal residual disease allowed in accordance with standard disease-specific diagnostic criteria]
• Previous HLA-matched related or unrelated donor must be available to donate cells again
• No rapid disease progression that would preclude completing the study
• No active brain or spinal cord malignancy
• Recovered from prior treatment and transplant side effects to < grade 2
• No requirement for systemic corticosteroids or other immunosuppressive drugs
• Topical agents and/or inhaled corticosteroids allowed
• No concurrent brain or spinal radiation therapy
• Concurrent treatment or prevention for brain or spinal leukemia or lymphoma allowed in patients with ALL, AML, and CML in blast crisis
• Concurrent hydroxyurea allowed
• Must be over 1 year and under 75 years of age
• Performance status (ECOG) 0–3
• Creatinine ≤ 1.5 x the upper limit of normal (ULN) based on age OR creatinine clearance ≥ 60 mL/min
• Total bilirubin ≤ 2.0 mg/dL
• ALT ≤ 5 x ULN based on age
• No significant active graft versus host disease > grade 1 acute, or extensive chronic
• No clinically significant systemic illness that would preclude study participation
• No HIV infection
• No active hepatitis infection
• Not pregnant or nursing; fertile patients must use effective contraception

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Treatment Plan:

This is a non-randomized pilot study of 12 patients.

• Patients receive one vaccine (WT-1 peptide-loaded allogeneic dendritic cell [DC]) under the skin (subcutaneously) and one between skin layers (intradermally) in Weeks 0, 2, 4, 6, 8, and 10
• Patients also receive donor lymphocytes in a vein (intravenously) over 15–30 minutes 1 hour after the vaccines in Weeks 0, 4, and 8
• Patients undergo skin testing before starting treatment and again in Months 1, 2, 3, 4, 6, 9, and 12 to check the response of the immune system
• Patients also undergo peripheral blood and bone marrow collection periodically during study
• After completion of study treatment, patients are seen at 3, 4, 6, 9, and 12 months

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 11/11/08
Updated: 6/12/08