Loading clinical trials...

IP ALT-803 Followed by SQ ALT-803 for Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

IP ALT-803 Followed by SQ ALT-803 for Ovarian Cancer

QUILT-2.021: Randomized Study of Single Course of Intraperitoneal (IP) ALT-803 Followed by Subcutaneous (SQ) Maintenance ALT-803 Versus Subcutaneous (SQ) Maintenance ALT-803 Only After 1st Line Chemotherapy for Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

NCT03054909•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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 therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or supraventricular tachyarrhythmia requiring chronic therapy)
•Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
•Uncontrolled bacterial, fungal or viral infections including HIV-1/2 or active hepatitis C/B - chronic asymptomatic viral hepatitis is allowed
•Active autoimmune disease requiring systemic immunosuppressive therapy
•History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
•Uncontrolled hypertension: defined as ≥2 readings over 160 mmHg systolic or 110 mmHg diastolic within month prior to enrollment despite optimal anti-hypertensive medication. Patients with high readings which improve to ≤160/110 after adjustment of medications will be eligible.
•History of pulmonary disease or abnormal pulmonary function studies
•History of narcolepsy or any neurological condition which may impair consciousness

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

September 19, 2017

Primary Completion Date

February 16, 2022

Completion Date

February 16, 2022

Last Updated

October 13, 2023

Enrollment

ACTUAL participants

Conditions

FIGO Stage III and IV Ovarian CancerFIGO Stage III and IV Fallopian Tube CancerFIGO Stage III Primary Peritoneal Cancer

Interventions

ALT-803 Subcutaneous

BIOLOGICAL

ALT-803 Intraperitoneal

BIOLOGICAL