LILOLA: A Study of Olaratumab Alone and in Combination with Standard Chemotherapies in Children with Cancer

A Study of Olaratumab Alone and in Combination with Standard Chemotherapies in Children with Cancer

Category:

Solid Tumor

Diseases Treated:

Cancer

Eligibility Overview:

  • Younger than 18 years old
  • Diagnosis of solid tumor that has not responded to treatment or came back after treatment (excluding melanoma and lymphomas)

 

  1. Brief Summary

    This study is a multicenter, open-label, dose-escalation Phase I pediatric safety clinical trial. Researchers will evaluate the investigational drug olaratumab as a single agent and in combination with either doxorubicin, vincristine/irinotecan, or high-dose ifosfamide in pediatric patients with relapsed or refractory solid tumors.

    Olaratumab is a recombinant human immunoglobulin subclass G1 (IgG1) monoclonal antibody that binds to PDGFRα. Preclinical and clinical data support exploring olaratumab in combination with standard chemotherapy regimens for patients with sarcomas and other pediatric tumors. Olaratumab has demonstrated antitumor activity when tested in adults with certain solid tumors.

    There are two parts to the study. Participants will enroll in only one part. Each part will consist of a 21-day cycle of olaratumab, followed by one of three standard chemotherapy regimens.

    Primary Objective

    • To determine a recommended dose of olaratumab in combination with at least one of the studied chemotherapy regiments in pediatric patients based on any dose-limiting toxicities as well as olaratumab serum exposure-matching between the adult and pediatric populations

    Secondary Objectives

    • To investigate the pharmacokinetics of olaratumab as monotherapy and in combination with either doxorubicin, vincristine/irinotecan or high-dose ifosfamide in pediatric patients
    • To assess the possible development of antibodies against olaratumab in pediatric patients
    • To document any anti-tumor activity observed

    Eligibility Criteria

    Inclusion criteria include:

    • Younger than 18 years old
    • Diagnosis of relapsed or refractory solid tumor (excluding lymphomas and melanoma but including central nervous system tumors) that is not amenable to curative treatment
    • Adequate hematologic, organ and coagulation function

    Exclusion Criteria include:

    • Hematologic malignancy
    • Bone marrow or solid organ transplant
    • Uncontrolled intercurrent illness
    • Active viral, fungal or bacterial infection
    • Pregnant or breastfeeding

    Study Design

    Multicenter, dose-escalation, open-label Phase I pediatric safety clinical trial with Part A and Part B

    Study Sites

    St. Jude Children’s Research Hospital, Memphis, Tennessee
    Collaborating sites in the U.S.

  2. About this study

    This study is being done to test the safety of an experimental drug called olaratumab in children, adolescents and young adults with certain kinds of solid tumors that are hard to treat. Researchers want to test the drug by itself and in combination with other anti-cancer medicines.

    Olaratumab has been tested in adults with solid tumors. In these tests, the drug seemed to slow tumor growth. Researchers want to find out if olaratumab will work the same way in children with solid tumors.

    The U.S. Food and Drug Administration (FDA) has approved the use of this drug for research. It has not approved the drug for normal clinical use.

    Purpose of this clinical trial

    The main purpose of this study is to find out the safest dose of olaratumab for children with solid tumors that are hard to treat. Researchers also want to know the good and bad effects of the drug and how it is handled by a child’s body.

    Eligibility overview

    • Younger than 18 years old
    • Diagnosis of solid tumor that has not responded to treatment or came back after treatment (excluding melanoma and lymphomas)

     

  3. LILOLA Quick View
    Sponsor Eli Lilly and Company
    Clinicaltrials.gov identifier NCT02677116
    Trial start date August 2016
    Estimated enrollment 70 (10 at St. Jude)
    Study type Interventional
    Study phase Phase I
    Conditions Solid Tumors
    Ages Younger than 18 years old
    Principal investigator Michael Bishop, MD
    Study site St. Jude Children’s Research Hospital and collaborating sites in and outside the U.S.
    For a consultation or to discuss LILOLA St. Jude Physician/Patient Referral Offic
    1-888-226-4343
    referralinfo@stjude.org

Contact

Michael Bishop, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.