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Neoplasms,OvarianPhase 1/2NCT02178670

Safety and Effectivity Immunotherapy to Treat Ovarian Cancer With Cancer Stem Cells Vaccine

A Phase 1/2 study testing CSC-DC in people with Neoplasms,Ovarian, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Neoplasms,Ovarian
What is being tested?
CSC-DC
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteChina
Study dates
Jun 2014to Apr 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Biological treatment center in Fuda cancer hospital

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic Adenocarcinoma of the Ovarian

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.

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

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

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

Being tested
CSC-DC
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CSC-DCBiological

Study groups in NCT02178670
Study groupRoleWhat they receive
non-cancer stem cell vaccinePlacebo comparatorThere is no cancer stem cell vaccine in this group
Receives: Biological: CSC-DC
giving low dose vaccineExperimentalThe using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
Receives: Biological: CSC-DC
giving middle dose vaccineExperimentalThe using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
Receives: Biological: CSC-DC
giving high dose vaccineExperimentalThe using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
Receives: Biological: CSC-DC

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 3 months

Secondary outcomes (1)

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

    The secondary objectives are to evaluate the vaccine immune responses including cellular immunity and humoral immunity

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02178670
Sponsor's protocol ID
CLO-001
Other IDs
201401
Status last verified
Jun 2014
First submitted
27 Jun 2014
Last updated
12 Sep 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22473314

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CSC-DC in people with Neoplasms,Ovarian, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02178670, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.

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