ALT-803 in Treating Patients with Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Diagnosis of Federation of Gynecology and Obstetrics (FIGO) stage III or grade IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma, has received at least 3 cycles of first line intravenous (IV)/IP cisplatin and paclitaxel chemotherapy and has stable disease or better. 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 is met
- Able to begin study therapy within 3 months of final dose of first line chemotherapy
- Functioning intraperitoneal catheter
- Gynecological Oncology Group (GOG) performance status =< 2
- hemoglobin > 8 g/dl
- Absolute neutrophil count (ANC) >= 1500/ul
- Absolute lymphocyte count (ALC) > 800/ul
- Platelets > 50 x 10^9/L
- Creatinine: =< 2.0 mg/dL
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 3 x upper limit of institutional normal (ULN)
- Ability to be off prednisone and other immunosuppressive drugs (< 1 mg/day) for at least 3 days prior to and while receiving ALT-803
- Voluntary written consent prior to the performance of any research related procedures
- Somatic or germline BRCA1 or BRCA2 mutations
- 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 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/corrected QC (QTc) interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
- Uncontrolled bacterial, fungal or viral infections including human immunodeficiency virus (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
I. To select a “winner” for future study with the intent to ensure that if one method is clearly inferior in terms of the primary endpoint of progression free survival (PFS) by 6 months of subcutaneous administration against intraperitoneal and subcutaneous administration of ALT-803.
I. To determine one and two year progression free survival (PFS).
II. To determine one and two year overall survival (OS).
III. To document ALT-803 associated toxicity when administered by intraperitoneal (IP) in this patient population.
IV. To evaluate the safety of ALT-803 when administered by IP on this schedule.
I. To evaluate peripheral blood and peritoneal washing lymphocyte number, phenotype and function.
II. To characterize ALT-803 immunogenicity.
III. To determine the genomic, transcriptomic, and proteomic profile of subjects’ tumors to identify gene mutations, gene amplifications, ribonucleic acid (RNA)-expression levels, and protein-expression levels.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ALT-803 subcutaneously (SC) on days 1, 8, 15, and 22. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive ALT-803 IP on days 1, 8, 15, and 22 of cycle 1 only and then SC on days 1, 8, 15, and 22 of cycles thereafter. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks and then every 3 weeks for 2 years from the start of treatment.
Trial Phase Phase II
Trial Type Treatment
University of Minnesota / Masonic Cancer Center
Melissa A. Geller
- Primary ID 2016LS034
- Secondary IDs NCI-2017-01337
- Clinicaltrials.gov ID NCT03054909