Gene Therapy Clinical Trials
Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for Treatment of High Risk Hematologic Malignancies
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: etoposide
- drug: bcnu
- drug: cyclophosphamide
- drug: gemcitabine
- drug: vinorelbine
- drug: melphalan
- drug: CIK cells
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.
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sherry Moore
6507257951
Not Recruiting