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

NCT00477035 | Completed Phase 1 DMC

• 3 other identifiers: IRB-0024595889BMT173
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia; Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• To document the toxicities of infusion of autologous CIK cells

  Day 42 post autologous stem cell transplant

• Measure freedom from progression (FFP)

  1 and 2 years post-transplant

• Measure event free survival

  1 and 2 years post-transplant

• Measure overall survival

  1 and 2 years post-transplant

Secondary Outcomes (1)

• Measure disease response

  at day 40-60, day 90, day 180, and yearly

Study Arms (1)

Autologous Cytokine-induced Killer Cells

EXPERIMENTAL

Drug: CIK cells; Drug: etoposide; Drug: bcnu; Drug: cyclophosphamide; Drug: gemcitabine; Drug: vinorelbine; Drug: melphalan

Interventions

CIK cells DRUG

2x10e8 cells/kg

Also known as: autologous cytokine-induced killer cells

Autologous Cytokine-induced Killer Cells

etoposide DRUG

60 mg/kg

Also known as: Eposin, Etopophos, Vepesid, VP-16

Autologous Cytokine-induced Killer Cells

bcnu DRUG

15 mg/kg

Also known as: Carmustine

Autologous Cytokine-induced Killer Cells

cyclophosphamide DRUG

100 mg/kg

Also known as: Endoxan, Cytoxan, Neosar, Procytox, Revimmune, cytophosphane

Autologous Cytokine-induced Killer Cells

gemcitabine DRUG

1250 mg/m2

Also known as: Gemzar

Autologous Cytokine-induced Killer Cells

vinorelbine DRUG

30 mg/m2

Also known as: Navelbine

Autologous Cytokine-induced Killer Cells

melphalan DRUG

200 mg/m2

Also known as: Alkeran, Melphalan hydrochloride

Autologous Cytokine-induced Killer Cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sally Arai: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Leukemia; Multiple Myeloma

Interventions

Etoposide; etoposide phosphate; Carmustine; Cyclophosphamide; Gemcitabine; Vinorelbine; Melphalan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sally Arai

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 22, 2007
• Study Start: May 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 11, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)