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

NCT ID: NCT00477035

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2011-03-31

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.

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.

Conditions

Leukemia; Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Autologous Cytokine-induced Killer Cells

Group Type: EXPERIMENTAL

CIK cells

Intervention Type: DRUG

2x10e8 cells/kg

etoposide

Intervention Type: DRUG

60 mg/kg

bcnu

Intervention Type: DRUG

15 mg/kg

cyclophosphamide

Intervention Type: DRUG

100 mg/kg

gemcitabine

Intervention Type: DRUG

1250 mg/m2

vinorelbine

Intervention Type: DRUG

30 mg/m2

melphalan

Intervention Type: DRUG

200 mg/m2

Interventions

CIK cells

2x10e8 cells/kg

Intervention Type: DRUG

etoposide

60 mg/kg

Intervention Type: DRUG

bcnu

15 mg/kg

Intervention Type: DRUG

cyclophosphamide

100 mg/kg

Intervention Type: DRUG

gemcitabine

1250 mg/m2

Intervention Type: DRUG

vinorelbine

30 mg/m2

Intervention Type: DRUG

melphalan

200 mg/m2

Intervention Type: DRUG

Other Intervention Names

autologous cytokine-induced killer cells; Eposin; Etopophos; Vepesid; VP-16; Carmustine; Endoxan; Cytoxan; Neosar; Procytox; Revimmune; cytophosphane; Gemzar; Navelbine; Alkeran; Melphalan hydrochloride

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sally Arai

OTHER

Sponsor Role: lead

Responsible Party

Sally Arai

Assistant Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sally Arai

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

95889

Identifier Type: OTHER

Identifier Source: secondary_id

BMT173

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-00245

Identifier Type: -

Identifier Source: org_study_id