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A PHASE II TRIAL OF Hu3S193 THERAPY FOR PATIENTS WITH PLATINUM REFRACTORY OR PLATINUM RESISTANT EPITHELIAL OVARIAN, PRIMARY PERITONEAL AND FALLOPIAN TUBE CANCER
RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying how well Hu3S193 works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.
OBJECTIVES: Primary * To evaluate the efficacy of monoclonal antibody Hu3S193 in women with platinum-resistant/refractory ovarian, fallopian tube, or primary peritoneal cancer, based on RECIST criteria (Response Evaluation Criteria in Solid Tumors). Secondary * To determine the safety of the study drug. * To determine the drug pharmacokinetics when administered in multiple weekly injections. Exploratory analysis * Clinical Benefit (objective response rate + tumor stabilization). * Progression Free Survival (PFS). * Duration of Response. * Overall Survival. * 12-month survival rate. OUTLINE: This is a multicenter study. Patients receive monoclonal antibody Hu3S193 IV over 1 hour once weekly in weeks 1-8. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed monthly.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, Brazil
Hospital da Baleia
Minas Gerais, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil
Instituto Nacional de Cancer
Rio de Janeiro, Brazil
Hospital das Clinicas FMUSP
São Paulo, Brazil
Hospital Sirio-Libanes
São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil
Start Date
May 1, 2008
Primary Completion Date
June 1, 2012
Completion Date
June 1, 2012
Last Updated
November 26, 2013
31
ACTUAL participants
hu3S193
BIOLOGICAL
Lead Sponsor
Recepta Biopharma
NCT04550494
NCT05039801
Data Source & Attribution
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