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

University of Minnesota (UMN)

Status and phase

Completed

Phase 2

Conditions

FIGO Stage III Primary Peritoneal Cancer

FIGO Stage III and IV Fallopian Tube Cancer

FIGO Stage III and IV Ovarian Cancer

Treatments

Biological: ALT-803 Subcutaneous

Biological: ALT-803 Intraperitoneal

Study type

Interventional

Funder types

Other

Identifiers

NCT03054909

2016LS034

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 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