Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Possible New Therapy for Advanced Cancer

This study has been terminated.
(Business decision by the sponsor.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
INSYS Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT01832974
First received: September 11, 2012
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Adrenocortical Carcinoma
Drug: IL-13-PE
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by INSYS Therapeutics Inc:

Primary Outcome Measures:
  • Maximum tolerated dose of IL-13-PE [ Time Frame: during 16-week dose-escalation treatment, up to 3 years ] [ Designated as safety issue: Yes ]
  • Best overall response [ Time Frame: during 16-week treatment, up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Estimated Progression-Free Survival [ Time Frame: during 16-week treatment and 12-month follow-up, up to 4 years ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: Indefinitely ] [ Designated as safety issue: Yes ]
    Following the 12-month follow-up evaluation patients will be followed via phone or e-mail contact every 6 months for survival


Enrollment: 9
Study Start Date: December 2012
Study Completion Date: September 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Electron Kebebew, M.D. National Institutes of Health (NIH)
  More Information

Publications:
Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT01832974     History of Changes
Other Study ID Numbers: 13-C-0046, 13-C-0046 D, P11946
Study First Received: September 11, 2012
Last Updated: November 18, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014