NCT02178670

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 Jun 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

June 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

September 12, 2019

Status Verified

June 1, 2014

Enrollment Period

10 months

First QC Date

June 27, 2014

Last Update Submit

September 10, 2019

Conditions

Neoplasms,Ovarian

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

There is no cancer stem cell vaccine in this group

Biological: CSC-DC

giving low dose vaccine

EXPERIMENTAL

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

Biological: CSC-DC

giving middle dose vaccine

EXPERIMENTAL

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

Biological: CSC-DC

giving high dose vaccine

EXPERIMENTAL

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

Biological: CSC-DC

Interventions

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

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with epithelial ovarian cancer FIGO (Fédération Internationale de Gynécologie et d'Obstétrique) stage III in remission after treatment with surgery (hysterectomy and ovariectomy) and after the first primary chemotherapy (standard treatment e.g. 6-9x Carboplatin/Taxane)
  • Age \> 18 ≤ 75 years
  • Histological confirmed FIGO stage III ovarian epithelial cancer
  • Stable disease at screening visit: negative CT and CA-125 within normal range
  • Karnofsky status ≥ 70% and/or ECOG (Eastern Cooperative Oncology Group) performance status 0-2
  • Life expectancy ≥ 6 months
  • Adequate hematological function (WBC (white blood cells) ≥ 3000/µl, hemoglobin ≥ 10.0 g/dL, platelets \> 100,000/µl)
  • Adequate renal and hepatic function (serum creatinine ≤ 2.0 mg/dL, bilirubin total \< 2 mg/dL, PT (INR) ≤ 1.5x institutional upper limit of normal)
  • Signed and dated informed consent before the start of any study-specific procedure
  • Body weight \> 50 kg

You may not qualify if:

  • Surgery, radiation therapy or chemotherapy within eight weeks prior to leukapheresis
  • Other biological therapy (Interferons, TNF (Tumor necrosis factors), Interleukins, mABs (Monoclonal antibodies), biological response modifiers) within eight weeks prior to undergo the leukapheresis
  • History or presence of systemic autoimmune disease (such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma or multiple sclerosis)
  • Participation in other clinical trials or treatments with an investigational drug within four weeks prior to enrollment
  • Serious intercurrent chronic or acute illness such as severe asthma or COPD (Chronic Obstructive Pulmonary Disease), cardiac (NYHA (New York Heart Association ) class III or IV) or hepatic disease, or other illness considered to constitute an unwarranted high risk for investigational drug treatment
  • History of another malignancy within five years prior to study enrollment, except curatively treated non-melanotic skin cancer or cervical cancer in situ
  • Presence of an active acute or chronic infection, including syphilis, HIV or viral hepatitis B and/or C
  • Current treatment with corticosteroids (except of local) or other immunosuppressive agents such as azathioprine or cyclosporine A is excluded on the basis of its potential immune suppression. Any systemic steroid therapy must have been discontinued six weeks prior to undergo the leukapheresis
  • Patients who have undergone organ transplantation
  • Legally incapacitated persons and/or other circumstances, which make it difficult for the subject to understand the nature, meaning and consequences of the clinical study

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

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

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

June 27, 2014

First Posted

July 1, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

September 12, 2019

Record last verified: 2014-06

Locations

CN(1)