- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02178670
Safety and Effectivity Immunotherapy to Treat Ovarian Cancer With Cancer Stem Cells Vaccine
Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic Adenocarcinoma of the Ovarian
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Biological treatment center in Fuda cancer hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: non-cancer stem cell vaccine
There is no cancer stem cell vaccine in this group
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EXPERIMENTAL: giving low dose vaccine
The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
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EXPERIMENTAL: giving middle dose vaccine
The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
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EXPERIMENTAL: giving high dose vaccine
The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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up to 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The secondary objectives are to evaluate vaccine immune responses to the immunizations by the data of body measurements
Time Frame: 1 month
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The secondary objectives are to evaluate the vaccine immune responses including cellular immunity and humoral immunity
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1 month
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Other Outcome Measures
Outcome Measure |
Time Frame |
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The dose of CSC vaccine
Time Frame: up to 3 months
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up to 3 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLO-001
- 201401 (Other Grant/Funding Number: The research fund of Fuda cancer hospital in Guangzhou)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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