Possible New Therapy for Advanced Cancer

Brief Title

Possible New Therapy for Advanced Cancer

Official Title

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

Brief Summary

      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 Phase

Phase 1

Study Type

Interventional

Primary Outcome

Maximum tolerated dose of IL-13-PE

Secondary Outcome

 Percentage of participants with clinically significant abnormal findings on physical examination

Condition

Adrenocortical Carcinoma

Intervention

IL-13-PE

Study Arms / Comparison Groups

 Part 1- 1 μg/kg

Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

9

Start Date

December 2012

Completion Date

September 2014

Primary Completion Date

March 2014

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Electron Kebebew, M.D., , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01832974

Organization ID

13-C-0046

Secondary IDs

13-C-0046 D

Responsible Party

Sponsor

Study Sponsor

INSYS Therapeutics Inc

Collaborators

 National Institutes of Health (NIH)

Study Sponsor

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

Verification Date

April 2015