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This is a blinded, randomized, parallel groups Phase II trial. Patients with platinum sensitive ovarian cancer (defined as time to progression > 6 months in the penultimate platinum containing regimen) and who had either a tumor response or a stable disease upon completing their last platinum containing regimen will be randomized to either vaccine regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be administered as a consolidation therapy within 8 weeks of last platinum administration.
The vaccination phase will include 6 administrations of the study drug at 4-week intervals. After vaccination, patients will be monitored for tumor response (if measurable tumor was present at baseline) and for relapse or progression during an 18-month follow-up after completion of vaccine treatment.
The total duration of the study will be 2 years. Assessment for tumor response, disease progression and recurrence will be conducted every 12 weeks from the end of treatment until documented disease progression.
This is a multicenter double-blind controlled randomized Phase II study to evaluate the activity of folate receptor alpha (FRα) peptide vaccine as a consolidation treatment following completion of no less than 4 cycles of a platinum containing regimen in patients with recurrent platinum sensitive, non-mucinous ovarian, fallopian tube or primary peritoneal cancer.
Patients enrolled will have received two or more previous platinum-containing regimen. Patients must be determined as platinum sensitive after completion of their penultimate platinum therapy prior to enrollment on this study. Platinum sensitivity is determined as >6 months and <24 months after completion of the patient's final platinum dose. In addition the patients will have demonstrated a tumor response or stable disease upon their last platinum-containing regimen (per RECIST 1.1 and/or CA-125 GCIG criteria) prior to enrolment in this study.
Following consent the patient eligibility will be confirmed. Patients will need to start treatment with study drug within 8 weeks of their last dose of a chemotherapeutic agent of the platinum-containing regimen.
Following randomization, patients will be administered TPIV200 with GM-CSF adjuvant or GM-CSF control alone. Patients will have tumor assessments done every 12 weeks ± 1 week for up to 2 years, until objective disease progression according to RECIST 1.1 or the patient withdraws consent.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Platinum Sensitive Ovarian Cancer
FRα peptide plus Adjuvant (GM-CSF), Adjuvant (GM-CSF) Alone
Not yet recruiting
Published on BioPortfolio: 2016-12-01T16:08:21-0500
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Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
Immunologic adjuvant and sensitizing agent.
Proposed as an adjuvant to cancer chemotherapy; may have radiation protective properties.
A non-depolarizing skeletal muscle relaxant similar to TUBOCURARINE. It is used as an anesthesia adjuvant.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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