Dendritic cell-based immunotherapy for ovrian cancer patients.

Dendritic cell-based immunotherapy for progressed or relapsed solid tumor (breast cancer,ovarian cancer, renal cell carcinoma) patient-Phase 2 clinical study.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000831

Enrollment

Registered

2013-08-27

Start date

2005-11-23

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : [Name: Autologous DC]: autologous hematopoietic stem cell-derived DC pulsed with autologous tumor cell lysate. [Dosage, schedule and injection route] : 1x10e8 DC

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: -Age: 20~69 years old -Systemic condition: ECOG<3 -Pregressed disease patients -Disease status : patients with metastatic ovarian cancer at diagnosis or relapsed after diagnosis -Pt with proper kidney, liver and bone marrow functions 1) Hb 10.0g/dl, WBC 3,500/ul, PLT 100,000/ul 2) Serum Creatinin level < 1.25 times of normal healthy people 3) Serum SGOT/SGPT level < 3 times of normal healthy people -Signed informed consent, volutarily

Exclusion criteria

Exclusion criteria: -Pts with active infection -Defects on heart, liver, lung, brain and/or kidney function. -Pregnant or women with possibility of pregnancy (positive with test.)

Design outcomes

Primary

Measure	Time frame
Safety and Efficacy of DC vaccine treatment - Grade 0~4 toxicity, elimination of clinical tumor burden (CR/PR/PD/SD)	—

Secondary

Measure	Time frame
Tumor antigen-specific immune monitoring from the peripheral blood -NK cell activity, lymphocyte proportion and function, cytokine secretion, and effector T cell induction.	—

Countries

Korea, Republic of

Contacts

Public ContactYongMan Kim

Asan Medical Center

Outcome results