Platinum-resistant Ovarian Cancer, Recurrent Ovarian Carcinoma
Conditions
Brief summary
This is an open, single-arm, phase I clinical trial to evaluate safety and efficacy and of 6b11-OCIK injection in the treatment of recurrent drug-resistant ovarian cancer
Detailed description
This is a phase I clinical trial of cytotoxic T cell injection induced by dendritic cells loaded with 6B11 anti-idiotype minibody (6b11-OCIK injection) for recurrent drug-resistant ovarian cancer. Main purpose of this research is to determine the maximum tolerable dose (MTD) of 6B11-OCIK injection in the treatment of patients with ovarian cancer. Moreover, secondary purpose is to evaluate the effect of 6B11-OCIK injection on the immune system of patients, the efficacy of autologous 6B11-OCIK injection in the treatment of patients with ovarian cancer obtain and the correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection. Thirdly, exploratory purpose is to evaluate the effect of 6B11-OCIK injection on laboratory examination.
Interventions
DRUG6B11-OCIK Injection
Two infusions of 6B11-OCIK will be performed at each chemotherapy cycle (Day 3 an Day 7) during the first three cycles, while PBMC will be collected before each cycle (Day -12) during the first three cycles.
DRUGDoxorubicin
Subjects will be adminitered 4\ 6 cycles of chemotherapy (Doxorubicin, 30 mg/m\^2 IV on Day 1 of every cycle)
Sponsors
Beijing Weixiao Biotechnology Development Limited
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 18-70 years old patients. 2. Diagnosed as Ovarian Cancer, who had relapsed after initial treatment; Relapse after drug resistance: clinical remission after early chemotherapy, but progression or relapse within 6 months after chemotherapy,or achieve no response after early chemotherapy. 3. Administered with Doxorubicin.
Exclusion criteria
1. Symptomatic and uncontrolled Brain metastasis or pia meningeal metastasis; Patients with spinal cord compression; Symptoms related to central nervous system lesions or symptoms indicating disease progression; 2. Corticosteroid drugs (or analogues) or drugs effecting the immune system were administered before infusion in 4 weeks. 3. Patients with interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonia; 4. Women with positive serum pregnancy test or lactation;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTD | 1 year | Determine the maximum tolerable dose (MTD) of 6B11-OCIK injection in the treatment of patients with ovarian cancer base on the AE, SAE and laboratory examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of the antinuclear antibody (ANA) | 1 year | Changes in the concentrations of the antinuclear antibody (ANA) in peripheral blood after 6B11-OCIK injection from baseline. |
| Changes of the C-reactive protein (CRP) | 1 year | Changes in the concentrations of the C-reactive protein (CRP) in peripheral blood after 6B11-OCIK injection from baseline. |
| Changes of the interleukin-6 (IL-6) | 1 year | Changes in the concentrations of the interleukin-6 (IL-6) in peripheral blood after 6B11-OCIK injection from baseline. |
| Changes of the immunoglobulin | 1 year | Changes in the concentrations of the immunoglobulin in peripheral blood after 6B11-OCIK injection from baseline. |
| Changes of the cell immunophenotype | 1 year | Changes in the concentrations of the cell immunophenotype (CD3+, CD3+CD4+, CD3+CD8+, CD3-CD56+, CD3-CD19+) in peripheral blood after 6B11-OCIK injection from baseline. |
| Disease control rate (DCR) | 3 years | Percentage of evaluable patients who achieved CR, PR and SD after treatment. |
| Progression Free Survival (PFS) | 3 years | The period from the first infusion of 6B11-OCIK to first PD or death from any cause. |
| Correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection. | 1 year | OC166-9 antigen expression and efficacy of 6B11-OCIK |
| Objective response rate (ORR) | 3 years | Percentage of patients who achieved CR and PR after treatment. |
Countries
China
Contacts
Primary ContactXiaohong Chang
Backup Contacthongyan Cheng
Outcome results
None listed