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Possible New Therapy for Advanced Cancer

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ClinicalTrials.gov Identifier: NCT01832974
Recruitment Status : Terminated (Business decision by the sponsor during Phase 1.)
First Posted : April 16, 2013
Last Update Posted : April 27, 2015
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Study Description
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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.


Condition or disease Intervention/treatment Phase
Adrenocortical Carcinoma Drug: IL-13-PE Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : December 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: Interleukin-13 PE38QQR
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 Name: Interleukin-13 PE38QQR
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 Name: 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 Name: Interleukin-13 PE38QQR


Outcome Measures
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Primary Outcome Measures :
  1. Maximum tolerated dose of IL-13-PE [ Time Frame: during 16-week dose-escalation treatment, up to 3 years ]
  2. Best overall response [ Time Frame: during 16-week treatment, up to 3 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Other Outcome Measures:
  1. Estimated Progression-Free Survival [ Time Frame: during 16-week treatment and 12-month follow-up, up to 4 years ]
  2. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT01832974


Locations
United States, Maryland
National Cancer Institute at the National Institutes of Health
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
INSYS Therapeutics Inc
National Institutes of Health (NIH)
Investigators
Principal Investigator: Electron Kebebew, M.D. National Institutes of Health (NIH)
More Information
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Publications:

Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT01832974     History of Changes
Other Study ID Numbers: 13-C-0046
13-C-0046 D ( Other Identifier: National Institutes of Health Clinical Center )
P11946 ( Other Identifier: INSYS Therapeutics Inc )
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: April 27, 2015
Last Verified: April 2015

Keywords provided by INSYS Therapeutics Inc:
Adrenal Gland Cancer
Treatment Refractory Malignancies
Metastatic Cancer

Additional relevant MeSH terms:
Carcinoma
Adrenocortical Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Adrenal Cortex Neoplasms
 Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases