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Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT02132988
Recruitment Status : Unknown
Verified May 2014 by Mackay Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : May 7, 2014
Last Update Posted : May 7, 2014
Sponsor:
Collaborator:
OBI Pharma, Inc
Information provided by (Responsible Party):
Mackay Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Biological: OPT-822/OPT-821 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Labeled Phase II Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study Start Date : November 2013
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: OPT-822/OPT-821 Biological: OPT-822/OPT-821



Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Until disease progression or up to 5 years after the enrollment ]

Secondary Outcome Measures :
  1. Disease Recurrence Rate [ Time Frame: At 2 years after the enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132988


Contacts
Contact: Fiona Chen 886-2-25433535 ext 3941 fionaeg0528@gmail.com

Locations
Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 104
Contact: Fiona Chen    886-2-25433535 ext 3941    fionaeg0528@gmail.com   
Sub-Investigator: Chih-Lung Chang, MD         
Principal Investigator: Yuh-Cheng Yang, MD         
Sponsors and Collaborators
Mackay Memorial Hospital
OBI Pharma, Inc

Responsible Party: Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT02132988     History of Changes
Other Study ID Numbers: MMH-OPT822-OC001
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders