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CSC: A Phase I/II Study of Active Immunotherapy With Cancer Stem Cells Vaccine for Colorectal Cancer

Sponsor
Fuda Cancer Hospital, Guangzhou (Other)
Overall Status
Completed
CT.gov ID
NCT02176746
Collaborator
University of Michigan (Other)
40
Enrollment
1
Location
4
Arms
11
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

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 anti-tumor immunity.

Condition or Disease Intervention/Treatment Phase
  • Biological: cancer stem cell vaccine
 Phase 1/Phase 2

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 colorectal cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the colorectal cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells from the tumor specimen of the colorectal cancer patient using a similar protocol as investigators reported .

Aim 1: To demonstrate, in vitro, the relative cellular anti-colorectal cancer CSC immunity induced by colorectal cancer CSC-DC primed cytotoxic T cells.

Aim 2: To determine, in vitro, specific binding and lysis of colorectal cancer CSCs by antibodies produced by purified B cells from PBMCs stimulated with colorectal cancer CSC-DC.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic Adenocarcinoma of the Colorectal
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: non-cancer stem cell vaccine

This is no cancer stem cells vaccine in this group

Biological: cancer stem cell vaccine
Experimental: giving low dose vaccine

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

Biological: cancer stem cell vaccine
Experimental: giving middle dose vaccine

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

Biological: cancer stem cell vaccine
Experimental: giving high dose vaccine

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

Biological: cancer stem cell vaccine

Outcome Measures

Primary Outcome Measures

  1. The number of participants with adverse events [up to 3 months]

Secondary Outcome Measures

  1. The secondary objectives are to evaluate vaccine immune responses to the immunizations by the data of body measurements [1 month]

Other Outcome Measures

  1. The dose of CSC vaccine [up to 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age:18 and over

  2. Performance status:Karnofsky 70-100%

  3. Life expectancy:Greater than 6 months

  4. Hematopoietic:Absolute neutrophil count at least 1000/mm 3,Hemoglobin at least 9 g/dL,Platelet count at least 100,000/mm^3

  5. Hepatic:Bilirubin less than 2.0 mg/dL No chronic or acute hepatic disease Renal:Creatinine less than 2.5 mg/dL

  6. Cardiovascular:

No chronic or acute cardiac disease (New York Heart Association class III or IV)

  1. Pulmonary:

No chronic or acute pulmonary illness such as asthma or chronic obstructive pulmonary disease

Exclusion Criteria:

  1. Patients receiving anticoagulation therapy.

  2. Patients receiving any other investigational agents.

  3. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV. 4、level 3 hypertension; 5、severe coronary disease; 6、 myelosuppression; 7、 respiratory disease; 8、 brain metastasis; 9、 chronic infections

Contacts and Locations

Locations

Site City State Country Postal Code
1 Biological treatment center in Fuda cancer hospital Guangzhou Guangdong China 510000

Sponsors and Collaborators

  • Fuda Cancer Hospital, Guangzhou
  • University of Michigan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier:
NCT02176746
Other Study ID Numbers:
  • CLC-001
First Posted:
Jun 27, 2014
Last Update Posted:
Sep 12, 2019
Last Verified:
Jun 1, 2014
Additional relevant MeSH terms:
Colorectal Neoplasms

Study Results

No Results Posted as of Sep 12, 2019