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

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ClinicalTrials.gov Identifier: NCT00477035
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):
Sally Arai, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Leukemia Multiple Myeloma Drug: CIK cells Drug: etoposide Drug: bcnu Drug: cyclophosphamide Drug: gemcitabine Drug: vinorelbine Drug: melphalan Phase 1

Detailed Description:
Disease relapse remains the major cause of treatment failure in autologous stem cell transplantation for patients with high-risk disease. Relapse after autologous transplant is in part due to the persistence of residual cancer cells. Cellular immunotherapy using activated autologous effector cells to recognize and kill tumor targets in a minimal disease state after transplant is a strategy being explored to reduce relapse and improve survival. We hypothesize that cytokine-induced killer (CIK) cell-based immunotherapy can reduce the relapse rate after high-risk autologous stem cell transplantation by treating post-transplant minimal residual disease.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase I Study of Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for the Treatment of High-risk Hematologic Malignancies
Study Start Date : May 2006
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Autologous Cytokine-induced Killer Cells Drug: CIK cells
2x10e8 cells/kg
Other Name: autologous cytokine-induced killer cells

Drug: etoposide
60 mg/kg
Other Names:
  • Eposin
  • Etopophos
  • Vepesid
  • VP-16

Drug: bcnu
15 mg/kg
Other Name: Carmustine

Drug: cyclophosphamide
100 mg/kg
Other Names:
  • Endoxan
  • Cytoxan
  • Neosar
  • Procytox
  • Revimmune
  • cytophosphane

Drug: gemcitabine
1250 mg/m2
Other Name: Gemzar

Drug: vinorelbine
30 mg/m2
Other Name: Navelbine

Drug: melphalan
200 mg/m2
Other Names:
  • Alkeran
  • Melphalan hydrochloride

Primary Outcome Measures :
  1. To document the toxicities of infusion of autologous CIK cells [ Time Frame: Day 42 post autologous stem cell transplant ]
  2. Measure freedom from progression (FFP) [ Time Frame: 1 and 2 years post-transplant ]
  3. Measure event free survival [ Time Frame: 1 and 2 years post-transplant ]
  4. Measure overall survival [ Time Frame: 1 and 2 years post-transplant ]

Secondary Outcome Measures :
  1. Measure disease response [ Time Frame: at day 40-60, day 90, day 180, and yearly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477035

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Sally Arai
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Principal Investigator: Sally Arai Stanford University
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Responsible Party: Sally Arai, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00477035    
Other Study ID Numbers: IRB-00245
95889 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BMT173 ( Other Identifier: OnCore )
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Myeloma
Hematologic Neoplasms
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents