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.
In this study all patients receive four 8 week cycles of ALT-803 consisting of 4 weekly doses followed by a 4 week rest (no treatment). As it is not known how intraperitoneal (IP) administration (a route of drug administration frequently used for gynecologic cancers) of ALT-803 compares to subcutaneous (SQ) administration, both routes of administration will be tested. The primary objective of this trial is to select one method of delivery for further testing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off)
Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Progression Free Survival
Incidence of Progression Free Survival after first treatment of ALT-803.
Time frame: 6 months
Progression Free Survival
Incidence of Progression Free Survival after first treatment of ALT-803.. Survival probability estimate.
Time frame: 1 year
Overall Survival
Overall Survival from start of ALT-803 dosing
Time frame: 1 year
ALT-803 Associated Toxicities
Incidence of ALT-803 associated toxicities after first treatment of ALT-803.
Time frame: 1 year
Incidence of Recorded Toxicity Grade 3 or Greater
Grade 3 adverse events or greater will be measured. A Grade 3 adverse event is defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling.
Time frame: 1 year
Progression Free Survival
Incidence of Progression Free Survival after first treatment of ALT-803.. Survival probability estimate.
Time frame: 2 years
Overall Survival
Overall Survival after first treatment of ALT-803.
Time frame: 2 year
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