Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Ovarian Cancer
Conditions
Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: OPT-822/OPT-821
Type: Biological
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the effect of OPT-822/OPT-821 on improving Progression-Free Survival (PFS) in subjects who have non-progressive epithelial ovarian, fallopian tube, or primary peritoneal cancer after cytoreductive surgery and platinum-based chemotherapy as initial treatment for primary disease or as salvage treatment for first relapse.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Female
Criteria: Inclusion Criteria:

- Female subjects ≥ 21 years of age with histologically confirmed ≥ stage II epithelial ovarian, fallopian tube, and primary peritoneal cancer at diagnosis

- Who have not progressed after initial treatment with cytoreductive surgery and at least 4 cycles of platinum-based chemotherapy.

OR

- Female subjects ≥ 21 years of age with first relapsed epithelial ovarian, fallopian tube, and primary peritoneal cancer (regardless of stage at diagnosis)

- Who have not progressed after received at least 4 additional cycles of platinum-based chemotherapy with or without having undergone secondary cytoreductive surgery .

Exclusion Criteria:

- Subjects with evidence of disease progression according to the GCIG CA125 criteria or RECIST 1.1 criteria.

- Subjects who are currently receiving any other concomitant anticancer therapy.

- Subjects with evidence of extra-abdominal metastasis.
Location
Mackay Memorial Hospital
Taipei, Taiwan
Status: Recruiting
Contact: Fiona Chen - 886-2-25433535 - fionaeg0528@gmail.com
Start Date
November 2013
Completion Date
November 2018
Sponsors
Mackay Memorial Hospital
Source
Mackay Memorial Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page