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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477035
• Other study ID #: IRB-00245
• Secondary ID: 95889BMT173
• Status: Completed
• Phase: Phase 1
• First received: May 18, 2007
• Last updated: January 9, 2017
• Start date: May 2006
• Est. completion date: March 2011

Study information

• Verified date: January 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Data and Safety Monitoring BoardUnited States: Scientific Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Leukemia
• Multiple Myeloma

Intervention

Drug:
• CIK cells
2x10e8 cells/kg
• etoposide
60 mg/kg
• bcnu
15 mg/kg
• cyclophosphamide
100 mg/kg
• gemcitabine
1250 mg/m2
• vinorelbine
30 mg/m2
• melphalan
200 mg/m2

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Sally Arai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To document the toxicities of infusion of autologous CIK cells		Day 42 post autologous stem cell transplant	Yes
Primary	Measure freedom from progression (FFP)		1 and 2 years post-transplant	No
Primary	Measure event free survival		1 and 2 years post-transplant	No
Primary	Measure overall survival		1 and 2 years post-transplant	No
Secondary	Measure disease response		at day 40-60, day 90, day 180, and yearly	No