NCT02084823

Brief Summary

Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors into immunosuppressed mice, preventing an assessment on the immunologic interactions and effects of CSCs. In this study, the investigators examined the vaccination effects produced by CSC-enriched populations from histologically distinct murine tumors after their inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more effective as an antigen source than unselected tumor cells in inducing protective antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and T cells were capable of selective targeting CSCs and conferring antitumor immunity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 3, 2015

Status Verified

March 1, 2014

Enrollment Period

7 months

First QC Date

March 9, 2014

Last Update Submit

June 1, 2015

Conditions

Neoplasms, Lung

Outcome Measures

Primary Outcomes (1)

  • The primary study purpose to determine the safety of immunization with cancer stem cells vaccine by the number of participants with adverse events

    up to 3 months

Secondary Outcomes (1)

  • The secondary objectives are to evaluate vaccine immune responses to the immunizations by the data of body measurements

    1 month

Other Outcomes (1)

  • The dose of CSC vaccine

    up to 3 months

Study Arms (4)

non-cancer stem cell vaccine

PLACEBO COMPARATOR

The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.

Biological: cancer stem cell vaccine

giving low dose vaccine

EXPERIMENTAL

The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.

Biological: cancer stem cell vaccine

giving middle dose vaccine

EXPERIMENTAL

The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.

Biological: cancer stem cell vaccine

giving high dose vaccine

EXPERIMENTAL

The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.

Biological: cancer stem cell vaccine

Interventions

cancer stem cell vaccineBIOLOGICAL
giving high dose vaccinegiving low dose vaccinegiving middle dose vaccinenon-cancer stem cell vaccine

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have histologically or cytologically confirmed adenocarcinoma of the lung.The site of the primary lesion should be confirmed radiologically, or surgically to be in the lung.
  • Patients must be deemed unresectable due to involvement of critical vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable.
  • Patients must have a primary or metastatic lesion measurable in at least one dimension by RECIST criteria within 4 weeks prior to entry of study .
  • More than 4 weeks must have elapsed from the time of major surgery or completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects.
  • Life expectancy of \>3 months. 6. Karnofsky performance status \>70%. 7. The patient shows normal organ function according to the following parameters(as measured within six weeks prior to treatment allocation):
  • Hemoglobin: Within normal range according to institutional standards; Absolute leukocyte count: Within normal range according to institutional standards; Absolute lymphocyte count: Within normal range according to institutional standards; Platelet count: Within normal range according to institutional standards; Alanine aminotransferase: ≤ 2.5 x Upper Limit of Normal (ULN); Aspartate aminotransferase: ≤ 2.5 x ULN; Total bilirubin: ≤ 1.5 x ULN. In the case of known Gilbert's syndrome ≤ 2 x ULN; Serum creatinine: 1.5 x ULN; Calculated creatinine clearance: \> 50 mL/min . 8. Age \>18 years. 9. No history of autoimmune diseases. 10. Ability to understand the study protocol and a willingness to sign a written informed consent document.

You may not qualify if:

  • \- 1. Patients receiving anticoagulation therapy. 2. Patients who have received prior gemcitabine or radiation therapy to the lung bed 3. Patients receiving any other investigational agents. 4. Patients with known brain metastases will be excluded because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse effects.
  • \. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
  • \. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV. 7. level 3 hypertension; 8. severe coronary disease; 9. myelosuppression; 10. respiratory disease; 11. brain metastasis; 12. chronic infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • Ning N, Pan Q, Zheng F, Teitz-Tennenbaum S, Egenti M, Yet J, Li M, Ginestier C, Wicha MS, Moyer JS, Prince ME, Xu Y, Zhang XL, Huang S, Chang AE, Li Q. Cancer stem cell vaccination confers significant antitumor immunity. Cancer Res. 2012 Apr 1;72(7):1853-64. doi: 10.1158/0008-5472.CAN-11-1400.

    PMID: 22473314RESULT

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2014

First Posted

March 12, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

June 3, 2015

Record last verified: 2014-03

Locations

CN(1)