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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sally Arai, Stanford University
ClinicalTrials.gov Identifier:
NCT00477035
First received: May 18, 2007
Last updated: January 9, 2017
Last verified: January 2017
  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.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

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

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

Enrollment: 22
Study Start Date: May 2006
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477035

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Sally Arai
Investigators
Principal Investigator: Sally Arai Stanford University
  More Information

Responsible Party: Sally Arai, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00477035     History of Changes
Other Study ID Numbers: IRB-00245  95889  BMT173 
Study First Received: May 18, 2007
Last Updated: January 9, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Etoposide
Cyclophosphamide
Melphalan
Vinorelbine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on January 19, 2017