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Clinical Trial 18983
Cancer Type: Gynecological Tumor
Interventions:FR alpha peptide vaccine; GM-CSF; Leukine (GM-CSF); sargramostatin (GM-CSF)
Study Type: Treatment
Phase of Study: Phase II
- Robert Wenham
A Randomized Multicenter Phase II Trial To Evaluate The Safety, Efficacy And Immunogenicity Of Vaccination With Folate Receptor Alpha Peptides Admixed With GM-CSF As A Vaccine Adjuvant Versus GM-CSF Alone In Patients With Platinum Sensitive Ovarian Cancer And A Response Or Stable Disease To Platinum Therapy
The goal of the study vaccine is to help the participant's body recognize ovarian cancer and keep it from coming back. It does this by targeting a protein (called folate receptor alpha) that is rare in healthy tissue but is common in ovarian cancer tissue. The study vaccine is made from protein pieces that are found on ovarian and breast cancers. To enhance the study vaccine, the protein pieces are mixed with what is called an adjuvant, which alerts the immune system. For this study, the adjuvant called granulocyte-macrophage colony stimulating factor (GM-CSF) will be mixed with the study vaccine prior to administration. The purpose of the study is to compare Folate receptor alpha (protein) and GM-CSF (adjuvant) to GM-CSF alone.
Primary Objectives: To determine the efficacy of hu-FRá peptide vaccine with GM-CSF immune adjuvant compared to GM-CSF alone assessed by progression-free survival (PFS) by RECIST. To evaluate the safety and tolerability of hu-FRá peptide vaccine with GM-CSF versus GM-CSF alone. Secondary Objectives: To determine the efficacy of hu-FRá peptide vaccine with GM-CSF immune adjuvant compared to immune adjuvant alone by assessment of: - Overall survival (OS), - Best overall response (CR+PR), and duration of response (DOR). - Disease control rate (CR+PR+SD). - Response Rate by irRECIST criteria. - Cancer Antigen (CA)-125 response (Gynecologic Cancer InterGroup [GCIG] criteria).