Study of 6b11-OCIK Injection Treatment in Patients With Recurrent Drug-resistant Ovarian Cancer
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 6B11-OCIK injection
|
Drug: 6B11-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.
Drug: Doxorubicin
Subjects will be adminitered 4~6 cycles of chemotherapy (Doxorubicin, 30 mg/m^2 IV on Day 1 of every cycle)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
- Objective response rate (ORR) [3 years]
Percentage of patients who achieved CR and PR after treatment.
- 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
Eligibility Criteria
Criteria
Inclusion criteria:
-
18-70 years old patients.
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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;
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Corticosteroid drugs (or analogues) or drugs effecting the immune system were administered before infusion in 4 weeks.
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Patients with interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonia;
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Women with positive serum pregnancy test or lactation;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University People's hospital | Beijing | China | 100044 |
Sponsors and Collaborators
- Peking University People's Hospital
- Beijing Weixiao Biotechnology Development Limited
Investigators
- Principal Investigator: Xiaohong Chang, Peking University People's Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 6B11-OCIK-I