Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Vaccines

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

A maximum of 6 doses of the polyvalent-KLH vaccine and OPT-821 will be administered to each patient as per the schedule. Bevacizumab will be administered once every two weeks until week 11 and then once every three weeks according to the schedule. When the 6 vaccinations of the polyvalent-KLH vaccine +OPT821 are completed, patients may still continue to receive bevacizumab on the once every three week schedule.

bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821

Paul Sabbatini, MD

The immune system of the body has the ability to fight and eliminate infections and cancers. Immune treatments, such as in this study, seek to teach the immune system to find and destroy cancer cells. The purpose of this study is to test whether it is safe to treat the cancer with a vaccine and another drug called bevacizumab (also known as Avastin).

Polyvalent Vaccine-KLH Conjugate + Opt-821 Given in Combination With Bevacizumab

A PILOT STUDY OF A POLYVALENT VACCINE-KLH CONJUGATE + OPT-821 GIVEN IN COMBINATION WITH BEVACIZUMAB IN PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN SECOND OR GREATER COMPLETE OR PARTIAL CLINICAL REMISSION

Toxicities evaluated by CTCAE version 4.0

when given in the presence of bevacizumab

Patients must have IgM titer \>1:80, or a fourfold increase in prevailing antibody titer if present at baseline. Twenty-one patients would be accrued, and if \>8 of 21 patients should meet these criteria for three or more antigens based on the immune response criteria, the study would be considered positive.

Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5mm.

Genentech, Inc.

Memorial Sloan Kettering Cancer Center

Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Paul Sabbatini, MD

Number of Participants With Adverse Events

Percentage of Participants Who Met the Immunogenicity Criteria (>/=3 Antigens) of the Vaccine

Progression-free Survival as Assessed By Multiplex Biomarker Panel of Angiogenesis Markers

Overall Study

Spots Global Cancer Trial Database for Polyvalent Vaccine-KLH Conjugate + Opt-821 Given in Combination With Bevacizumab

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial