A Phase 1 interventional study of IL-13-PE in Adrenocortical Carcinoma, sponsored by INSYS Therapeutics Inc. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-27.
Sponsored by INSYS Therapeutics Inc · Phase 1, Interventional, and Basic science
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 9 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →INSYS Therapeutics Inc is the lead sponsor of 45 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
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
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
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
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
Also known as: Interleukin-13 PE38QQR
Maximum tolerated dose of IL-13-PE
Time frame: during 16-week dose-escalation treatment, up to 3 years
Best overall response
Time frame: during 16-week treatment, up to 3 years
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
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
Estimated Progression-Free Survival
Time frame: during 16-week treatment and 12-month follow-up, up to 4 years
Survival
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
This study is terminated, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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INSYS Therapeutics Inc