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

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ClinicalTrials.gov Identifier: NCT03054909
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief 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.

Condition or disease Intervention/treatment Phase
FIGO Stage III and IV Ovarian Cancer FIGO Stage III and IV Fallopian Tube Cancer FIGO Stage III Primary Peritoneal Cancer Biological: ALT-803 Subcutaneous Biological: ALT-803 Intraperitoneal Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 19, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: Arm 1: ALT-803 subcutaneous only Biological: ALT-803 Subcutaneous
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)

Experimental: Arm 2: ALT-803 intraperitoneal and subcutaneous Biological: ALT-803 Intraperitoneal
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).




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 6 months ]
    Incidence of Progression Free Survival


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 1 and 2 year ]
    Incidence of Progression Free Survival from start of ALT-803 dosing

  2. Overall Survival [ Time Frame: 1 and 2 year ]
    Overall Survival from start of ALT-803 dosing

  3. ALT-803 associated toxicities [ Time Frame: 1 year ]
    Incidence of ALT-803 associated toxicities

  4. Incidence of no recorded toxicity grade 3 or greater [ Time Frame: 1 year ]
    The safety of ALT-803 will be documented by lack of grade 3 and greater toxicity.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054909


Contacts
Contact: Melissa Geller, MD 612-624-0123 gelle005@umn.edu

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Melissa Geller, MD    612-624-0123    gelle005@umn.edu   
Principal Investigator: Melissa Geller, MD         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Melissa Geller, MD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT03054909     History of Changes
Other Study ID Numbers: 2016LS034
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Abdominal Neoplasms
Digestive System Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Digestive System Diseases
Peritoneal Diseases