Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for Treatment of High Risk Hematologic Malignancies

Not Recruiting

Trial ID: NCT00477035

Purpose

The purpose of the study is to conduct a phase I study of adoptive immunotherapy with autologous, ex-vivo expanded cytokine-induced killer (CIK) cells to reduce the relapse rate in autologous stem cell transplant patients with high-risk hematologic malignancies.

Official Title

A Phase I Study of Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for the Treatment of High-risk Hematologic Malignancies

Stanford Investigator(s)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Eligibility


Inclusion Criteria:

   - Patients between 18 and 75 years of age, inclusive candidates for standard autologous
   SCT who are at high risk for relapse:

      - Acute myelogenous leukemia (AML), high risk, in CR1 or beyond without a donor
      (CR1 defined as: normal bone marrow morphology, resolution of any previously
      abnormal karyotype, neutrophils > 1000/ul, platelets > 100,000/ul, independence
      from red cell transfusion, no evidence extramedullary leukemia)

      - Hodgkin's lymphoma relapsed or refractory, with the presence of >= 1 adverse risk
      factor (Adverse risk factors are defined as stage IV involvement of the lung or
      bone marrow, constitutional symptoms, and the presence of more than minimal
      residual disease before the preparatory regimen)

      - Multiple myeloma with high risk features with only single autologous transplant
      option. High risk features defined as IgA myeloma, B2M > 2.5 mg/ml with normal
      kidney function, complex karyotypes or isolated chromosome 13 abnormalities,
      standard-dose therapy > 12 months, or inability to achieve at least 50% reduction
      of plasma cells in the bone marrow or 50% reduction in the paraprotein
      concentration after initial induction chemotherapy prior to transplant.

   - Patients must have ECOG performance status < 2

   - Patients must have adequate renal function with a serum creatinine of < 2 mg/dl or
   creatinine clearance > 50 ml/min.

   - Patients must have adequate liver function with a total bilirubin < 2 mg/dl or
   transaminases < 3 times the upper limit of normal.

   - Patients must have negative antibody serology for human immunodeficiency virus (HIV1
   and 2)

   - Adult women and minorities will be included. Patients with childbearing potential must
   use effective contraception.

   - Patients must sign informed consent prior to initiation of any study-related
   treatments.

Exclusion Criteria:

   - ECOG performance status > 2

   - LVEF < 45%

   - Pulmonary diffusion capacity < 50% predicted

   - Total bilirubin > 2 mg/dl

   - Creatinine > 2 mg/dl

   - Pregnancy

   - Patients positive for HIV

   - Patients with engraftment failure at day 42 post transplant defined as failure to
   achieve a granulocyte count > 500/ul on 3 successive daily determinations and an
   unsupported platelet count of >= 50,000/ul by day 42

   - Patients with active, uncontrolled infection that is expected to continue beyond day
   42-63.

   - Patients who fail to collect sufficient quantities of stem cells (> 1.6 x 10^9 cells)
   during apheresis to support CIK cell expansion cultures.

Intervention(s):

drug: etoposide

drug: bcnu

drug: cyclophosphamide

drug: gemcitabine

drug: vinorelbine

drug: melphalan

drug: CIK cells

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sherry Moore
6507257951

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