IP ALT-803 Followed by SQ ALT-803 for Ovarian Cancer (NCT03054909) | Clinical Trial Compass
CompletedPhase 2
IP ALT-803 Followed by SQ ALT-803 for Ovarian Cancer
United States7 participantsStarted 2017-09-19
Plain-language summary
This is a single center, randomized phase II study of an IL-15Rα-Fc super-agonist complex (ALT-803) given as maintenance therapy after the completion of 1st line IV/IP chemotherapy for the treatment of advanced ovarian, fallopian tube, and primary peritoneal cancer.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Diagnosis of FIGO stage III or grade IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma, has received at least 3 cycles of first line IV/IP cisplatin and paclitaxel chemotherapy and has stable disease or better - refer to Appendix II for FIGO staging system (Note: to be eligible for this study, the patient must receive a minimum of 3 cycles of IP therapy; however, patients may continue on IV only 1st line therapy for additional cycles as long as inclusion criteria 4.1.2 is met)
* Able to begin study therapy within 3 months of final dose of first line chemotherapy
* Functioning intraperitoneal catheter
* ≥ 18 years of age
* GOG performance status ≤ 2 (Appendix II)
* Adequate organ function within 14 days of enrollment defined as:
* Hematology: hemoglobin ≥ 8 g/dl, absolute neutrophil count (ANC) ≥ 1500/ul, platelets ≥ 50 x 109/L
* Creatinine: ≤ 2.0 mg/dL
* Hepatic: SGOT and SGPT ≤ 3 x upper limit of institutional normal (ULN)
* Ability to be off prednisone and other immunosuppressive drugs for at least 3 days prior to and while receiving ALT-803
* Voluntary written consent prior to the performance of any research related procedures
Exclusion Criteria
* Received any investigational agent within the 14 days before the start of ALT-803
* Class II or greater New York Heart Association Functional Classification criteria (Appendix II) or serious cardiac arrhythmias likely to increase the risk of cardiac complications of cytokine ther…
What they're measuring
1
Progression Free Survival
Timeframe: 6 months
Trial details
NCT IDNCT03054909
SponsorMasonic Cancer Center, University of Minnesota