Study of 6b11-OCIK Injection Treatment in Patients With Recurrent Drug-resistant Ovarian Cancer

Study Overview
=================
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.

Official Title
-----------------
A Phase I Study of Autologous Killer Cell Injection Induced by Dendritic Dells Loaded With 6B11 Anti-idiotype Minibody (6b11 - OCIK Injection) Treatment in Patients With Recurrent Drug-resistant Ovarian Cancer

Conditions
-----------------
Recurrent Ovarian Carcinoma, Platinum-resistant Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: 6B11-OCIK Injection
* Drug: Doxorubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 18-70 years old patients. 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. Administered with Doxorubicin. Exclusion criteria: 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; Corticosteroid drugs (or analogues) or drugs effecting the immune system were administered before infusion in 4 weeks. Patients with interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonia; Women with positive serum pregnancy test or lactation;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6B11-OCIK injection<br> | Drug: 6B11-OCIK Injection<br>* 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.<br>Drug: Doxorubicin<br>* Subjects will be adminitered 4 6 cycles of chemotherapy (Doxorubicin, 30 mg/m^2 IV on Day 1 of every cycle)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTD | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the cell immunophenotype | 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. | 1 year | 
| Changes of the antinuclear antibody (ANA) | Changes in the concentrations of the antinuclear antibody (ANA) in peripheral blood after 6B11-OCIK injection from baseline. | 1 year | 
| Changes of the C-reactive protein (CRP) | Changes in the concentrations of the C-reactive protein (CRP) in peripheral blood after 6B11-OCIK injection from baseline. | 1 year | 
| Changes of the interleukin-6 (IL-6) | Changes in the concentrations of the interleukin-6 (IL-6) in peripheral blood after 6B11-OCIK injection from baseline. | 1 year | 
| Changes of the immunoglobulin | Changes in the concentrations of the immunoglobulin in peripheral blood after 6B11-OCIK injection from baseline. | 1 year | 
| Objective response rate (ORR) | Percentage of patients who achieved CR and PR after treatment. | 3 years | 
| Disease control rate (DCR) | Percentage of evaluable patients who achieved CR, PR and SD after treatment. | 3 years | 
| Progression Free Survival (PFS) | The period from the first infusion of 6B11-OCIK to first PD or death from any cause. | 3 years | 
| Correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection. | OC166-9 antigen expression and efficacy of 6B11-OCIK | 1 year |