Back to results

The Immunotherapy of Nasopharyngeal Cancer Using Cancer Stem Cells Vaccine

Primary Purpose

Neoplasms, Lung

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

cancer stem cell vaccine

About this trial

This is an interventional treatment trial for Neoplasms, Lung

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1.patients are greater than 18 years of age, with advanced local disease (T3-T4N0-1M0), nodal disease (T1-T2N2-3M0) and loco-regional disease (T3-T4N2-3M0) at onset but presently controlled by standard therapy (combination of chemotherapy and radiotherapy) or with completely resected metastatic disease.
2.Pathologic confirmation of nasopharyngeal carcinoma by the NCI Laboratory of Pathology (NPC).
3.serum creatinine of 2.0 mg/dl or less. 4.Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
5.WBC 3000/mm(3) or greater. 6.platelet count 90,000 mm(3) or greater. 7.serum AST/ALT less than three times normal. 8.ECOG performance status of 0 or 1. 9.Patients of both genders must be willing to practice effective birth control during this trial because the potential for teratogenic effects are unknown.
10.Patients may have had prior adjuvant treatment or may have had treatment for metastatic disease and are now with no evidence of disease, including chemotherapy or biotherapy, as long as 1 month has elapsed since prior systemic therapy.

Exclusion Criteria:

1. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV. 2. level 3 hypertension; 3. severe coronary disease; 4. myelosuppression; 5. respiratory disease; 6. brain metastasis; 7. chronic infections

Sites / Locations

Biological treatment center in Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

non-cancer stem cell vaccine

giving low dose vaccine

giving middle dose vaccine

giving high dose vaccine

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02115958

First Posted

April 14, 2014

Last Updated

September 10, 2019

Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT02115958

Brief Title

The Immunotherapy of Nasopharyngeal Cancer Using Cancer Stem Cells Vaccine

Official Title

Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic of the Nasopharynx

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

University of Michigan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the investigators will harvest peripheral blood and tumor specimen from patients with Nasopharyngeal Cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the nasopharyngeal cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells from the tumor specimen of the nasopharyngeal cancer patient using a similar protocol as investigators reported . Aim 1: To demonstrate, in vitro, the relative cellular anti-nasopharyngeal cancer CSC immunity induced by nasopharyngeal cancer CSC-DC primed cytotoxic T cells. Aim 2: To determine, in vitro, specific binding and lysis of nasopharyngeal cancer CSCs by antibodies produced by purified B cells from PBMCs stimulated with nasopharyngeal cancer CSC-DC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasms, Lung

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

non-cancer stem cell vaccine

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

giving low dose vaccine

Arm Type

Experimental

Arm Description

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

Arm Title

giving middle dose vaccine

Arm Type

Experimental

Arm Description

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

Arm Title

giving high dose vaccine

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

cancer stem cell vaccine

Primary Outcome Measure Information:

Title

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

Time Frame

up to 3 months

Secondary Outcome Measure Information:

Title

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

Time Frame

1 month

Other Pre-specified Outcome Measures:

Title

The dose of CSC vaccine

Time Frame

up to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1.patients are greater than 18 years of age, with advanced local disease (T3-T4N0-1M0), nodal disease (T1-T2N2-3M0) and loco-regional disease (T3-T4N2-3M0) at onset but presently controlled by standard therapy (combination of chemotherapy and radiotherapy) or with completely resected metastatic disease. 2.Pathologic confirmation of nasopharyngeal carcinoma by the NCI Laboratory of Pathology (NPC). 3.serum creatinine of 2.0 mg/dl or less. 4.Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. 5.WBC 3000/mm(3) or greater. 6.platelet count 90,000 mm(3) or greater. 7.serum AST/ALT less than three times normal. 8.ECOG performance status of 0 or 1. 9.Patients of both genders must be willing to practice effective birth control during this trial because the potential for teratogenic effects are unknown. 10.Patients may have had prior adjuvant treatment or may have had treatment for metastatic disease and are now with no evidence of disease, including chemotherapy or biotherapy, as long as 1 month has elapsed since prior systemic therapy. Exclusion Criteria: 1. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV. 2. level 3 hypertension; 3. severe coronary disease; 4. myelosuppression; 5. respiratory disease; 6. brain metastasis; 7. chronic infections

Facility Information:

Facility Name

Biological treatment center in Fuda cancer hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

22473314

Citation

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.

Results Reference

result

Links:

URL

http://www.fudahospital.com/

Description

Related Info

Learn more about this trial

The Immunotherapy of Nasopharyngeal Cancer Using Cancer Stem Cells Vaccine

We'll reach out to this number within 24 hrs