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Possible New Therapy for Advanced Cancer

Primary Purpose

Adrenocortical Carcinoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IL-13-PE
Sponsored by
INSYS Therapeutics Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Adrenocortical Carcinoma focused on measuring Adrenal Gland Cancer, Treatment Refractory Malignancies, Metastatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Institute at the National Institutes of Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Experimental

Arm Label

Part 1- 1 μg/kg

Part 1 - 2 μg/kg

Part 1 - 3 μg/kg

Part 2 - All Participants

Arm 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

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

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

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)

Outcomes

Primary Outcome Measures

Maximum tolerated dose of IL-13-PE
Best overall response

Secondary Outcome Measures

Percentage of participants with clinically significant abnormal findings on physical examination
Percentage of participants with clinically significant abnormal findings on laboratory evaluation

Full Information

First Posted
September 11, 2012
Last Updated
April 24, 2015
Sponsor
INSYS Therapeutics Inc
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01832974
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Business decision by the sponsor during Phase 1.
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
INSYS Therapeutics Inc
Collaborators
National Institutes of Health (NIH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenocortical Carcinoma
Keywords
Adrenal Gland Cancer, Treatment Refractory Malignancies, Metastatic Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1- 1 μg/kg
Arm Type
Other
Arm 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
Arm Title
Part 1 - 2 μg/kg
Arm Type
Other
Arm Description
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
Arm Title
Part 1 - 3 μg/kg
Arm Type
Other
Arm Description
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
Arm Title
Part 2 - All Participants
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
IL-13-PE
Other Intervention Name(s)
Interleukin-13 PE38QQR
Intervention Description
IL-13-PE intravenous infusion
Primary Outcome Measure Information:
Title
Maximum tolerated dose of IL-13-PE
Time Frame
during 16-week dose-escalation treatment, up to 3 years
Title
Best overall response
Time Frame
during 16-week treatment, up to 3 years
Secondary Outcome Measure Information:
Title
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
Title
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 Pre-specified Outcome Measures:
Title
Estimated Progression-Free Survival
Time Frame
during 16-week treatment and 12-month follow-up, up to 4 years
Title
Survival
Description
Following the 12-month follow-up evaluation patients will be followed via phone or e-mail contact every 6 months for survival
Time Frame
Indefinitely

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Electron Kebebew, M.D.
Organizational Affiliation
National Institutes of Health (NIH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute at the National Institutes of Health
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22570059
Citation
Jain M, Zhang L, He M, Patterson EE, Nilubol N, Fojo AT, Joshi B, Puri R, Kebebew E. Interleukin-13 receptor alpha2 is a novel therapeutic target for human adrenocortical carcinoma. Cancer. 2012 Nov 15;118(22):5698-708. doi: 10.1002/cncr.27629. Epub 2012 May 8.
Results Reference
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PubMed Identifier
18973179
Citation
Bilimoria KY, Shen WT, Elaraj D, Bentrem DJ, Winchester DJ, Kebebew E, Sturgeon C. Adrenocortical carcinoma in the United States: treatment utilization and prognostic factors. Cancer. 2008 Dec 1;113(11):3130-6. doi: 10.1002/cncr.23886.
Results Reference
background
PubMed Identifier
21386792
Citation
Fassnacht M, Libe R, Kroiss M, Allolio B. Adrenocortical carcinoma: a clinician's update. Nat Rev Endocrinol. 2011 Jun;7(6):323-35. doi: 10.1038/nrendo.2010.235. Epub 2011 Mar 8.
Results Reference
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Possible New Therapy for Advanced Cancer

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