Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for Treatment of High Risk Hematologic Malignancies
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| ClinicalTrials.gov Identifier: NCT00477035 |
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Recruitment Status :
Completed
First Posted : May 22, 2007
Last Update Posted : January 11, 2017
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Sponsor:
Sally Arai
Information provided by (Responsible Party):
Sally Arai, Stanford University
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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 |
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.
| 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
MedlinePlus Genetics related topics:
Multiple myeloma
| 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:
Drug: bcnu 15 mg/kg
Other Name: Carmustine Drug: cyclophosphamide 100 mg/kg
Other Names:
Drug: gemcitabine 1250 mg/m2
Other Name: Gemzar Drug: vinorelbine 30 mg/m2
Other Name: Navelbine Drug: melphalan 200 mg/m2
Other Names:
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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 ]
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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 |
Criteria
Inclusion Criteria:
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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
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 |
| 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 Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
Neoplasms by Site Gemcitabine Cyclophosphamide Melphalan Carmustine Etoposide Vinorelbine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |