Clinical Trials /

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

NCT03054909

Description:

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.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: IP ALT-803 Followed by SQ ALT-803 for Ovarian Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 2016LS034
  • NCT ID: NCT03054909

Conditions

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

Interventions

DrugSynonymsArms
ALT-803 SubcutaneousArm 1: ALT-803 subcutaneous only
ALT-803 IntraperitonealArm 2: ALT-803 intraperitoneal and subcutaneous

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm 1: ALT-803 subcutaneous onlyExperimental
  • ALT-803 Subcutaneous
Arm 2: ALT-803 intraperitoneal and subcutaneousExperimental
  • ALT-803 Intraperitoneal

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival
Time Frame:6 months
Safety Issue:
Description:Incidence of Progression Free Survival

Secondary Outcome Measures

Measure:Progression Free Survival
Time Frame:1 and 2 year
Safety Issue:
Description:Incidence of Progression Free Survival from start of ALT-803 dosing
Measure:Overall Survival
Time Frame:1 and 2 year
Safety Issue:
Description:Overall Survival from start of ALT-803 dosing
Measure:ALT-803 associated toxicities
Time Frame:1 year
Safety Issue:
Description:Incidence of ALT-803 associated toxicities
Measure:Incidence of no recorded toxicity grade 3 or greater
Time Frame:1 year
Safety Issue:
Description:The safety of ALT-803 will be documented by lack of grade 3 and greater toxicity.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Masonic Cancer Center, University of Minnesota

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