Clinical trial NCT01832974: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Adrenocortical Carcinoma
Keywords: Adrenal Gland Cancer
Treatment Refractory Malignancies
Metastatic Cancer
Lead sponsor: INSYS Therapeutics Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
First posted: 2013-04-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Maximum tolerated dose of IL-13-PE
timeFrame: during 16-week dose-escalation treatment, up to 3 years
measure: Best overall response
timeFrame: during 16-week treatment, up to 3 years
Secondary outcomes:
measure: Percentage of participants with clinically significant abnormal findings on physical examination
timeFrame: during 16-week treatment and 12-month follow-up, up to 4 years
measure: Percentage of participants with clinically significant abnormal findings on laboratory evaluation
timeFrame: during 16-week treatment and 12-month follow-up, up to 4 years
Other outcomes:
measure: Estimated Progression-Free Survival
timeFrame: during 16-week treatment and 12-month follow-up, up to 4 years
measure: Survival
timeFrame: Indefinitely
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute at the National Institutes of Health
state: Maryland
Study officials:
affiliation: National Institutes of Health (NIH)
name: Electron Kebebew, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.