Possible New Therapy for Advanced Cancer

April 24, 2015 updated by: INSYS Therapeutics Inc

A Phase I/II Trial of IL-13-PE in Patients With Treatment Refractory Malignancies With a Focus on Metastatic and Locally Advanced Adrenocortical Carcinoma

IL-13-PE is a chemical similar to one made by the body that is connected to a toxin to specifically attack cancer cells. Researchers want to look at different doses of IL-13-PE to find one that may be safe and effective against cancer that has returned, spread to other organs, or that cannot be surgically removed.

Participants will receive physical exams and report side effects. Blood and urine samples will be collected. Imaging studies, tissue samples, and other tests will be used to study the tumor before the start of treatment and during the study. IL-13-PE therapy will be given to each participant on days 1, 3 and 5 of each monthly cycle for up to 4 monthly cycles.

The study will be done in two parts, with a six-month period between them. If the cancer continues to grow, participants will stop taking IL-13-PE. If the cancer continues to shrink or not grow the study will continue, even into a follow-up period after the second part of the study.

The first part of this study will determine how much IL-13-PE can be tolerated. For this part, the study is recruiting adult patients with various types of cancer. After six participants have taken the lowest dose with no more than one experiencing dose-limiting toxicity, two participants may begin the study taking the medium dose. If they tolerate the medium dose for a month, up to four more may begin at that dose. When at least three participants have tolerated the medium dose, two may attempt the highest dose. When they have tolerated the highest dose for one monthly cycle, 1-4 more may begin the study, receiving the highest dose.

Adrenal cortex cancer (ACC) is a rare tumor in the gland above the kidney. It affects only 1-2 people per million each year and causes hormone problems. This tumor affects children under age 5 and adults aged 30-40, causing death within five years for up to 80% of them. During the second part of the study, all participants will be ACC patients. They will receive the highest dose tolerated during Part 1 on days 1, 3, and 5 of each monthly cycle for up to four months.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute at the National Institutes of Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria at presentation
  • Has failed standard treatment
  • Has met protocol-specified criteria for qualification and contraception
  • Has voluntarily consented to participate and provided written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

  • Has history or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
  • Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
  • the safety or well-being of the participant or study staff
  • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  • the analysis of results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Part 1- 1 μg/kg
Up to 6 participants receiving IL-13-PE 1 μg/kg (rounded down to the nearest vial size within 10% of the calculated dose), intravenous (IV), Days 1, 3 and 5 in each monthly cycle for up to 4 cycles
Drug: IL-13-PE
IL-13-PE intravenous infusion
Other Names:
  • Interleukin-13 PE38QQR
OTHER: Part 1 - 2 μg/kg
If lower dose was tolerated, 3-6 participants receiving IL-13-PE 2 μg/kg (rounded down to the nearest vial size within 10% of the calculated dose), intravenous (IV), Days 1, 3 and 5 in each monthly cycle for up to 4 cycles
Drug: IL-13-PE
IL-13-PE intravenous infusion
Other Names:
  • Interleukin-13 PE38QQR
OTHER: Part 1 - 3 μg/kg
If lower dose was tolerated, 3-6 participants receiving IL-13-PE 3 μg/kg (rounded down to the nearest vial size within 10% of the calculated dose), intravenous (IV), Days 1, 3 and 5 in each monthly cycle for up to 4 cycles
Drug: IL-13-PE
IL-13-PE intravenous infusion
Other Names:
  • Interleukin-13 PE38QQR
EXPERIMENTAL: Part 2 - All Participants
All participants in Part 2, receiving maximum tolerated dose of IL-13-PE 1-3 μg/kg (rounded down to the nearest vial size within 10% of the calculated dose), intravenous (IV), 3 times per monthly cycle for up to 4 cycles (or longer for participants receiving clinical benefit)
Drug: IL-13-PE
IL-13-PE intravenous infusion
Other Names:
  • Interleukin-13 PE38QQR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose of IL-13-PE
Time Frame: during 16-week dose-escalation treatment, up to 3 years
during 16-week dose-escalation treatment, up to 3 years
Best overall response
Time Frame: during 16-week treatment, up to 3 years
during 16-week treatment, up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with clinically significant abnormal findings on physical examination
Time Frame: during 16-week treatment and 12-month follow-up, up to 4 years
during 16-week treatment and 12-month follow-up, up to 4 years
Percentage of participants with clinically significant abnormal findings on laboratory evaluation
Time Frame: during 16-week treatment and 12-month follow-up, up to 4 years
during 16-week treatment and 12-month follow-up, up to 4 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Progression-Free Survival
Time Frame: during 16-week treatment and 12-month follow-up, up to 4 years
during 16-week treatment and 12-month follow-up, up to 4 years
Survival
Time Frame: Indefinitely
Following the 12-month follow-up evaluation patients will be followed via phone or e-mail contact every 6 months for survival
Indefinitely

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

INSYS Therapeutics Inc

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Electron Kebebew, M.D., National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

April 12, 2013

First Posted (ESTIMATE)

April 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2015

Last Update Submitted That Met QC Criteria

April 24, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-C-0046
  • 13-C-0046 D (OTHER: National Institutes of Health Clinical Center)
  • P11946 (OTHER: INSYS Therapeutics Inc)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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