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| ID | Type | Description | Link |
|---|---|---|---|
| 13-C-0046 D | Other Identifier | National Institutes of Health Clinical Center | |
| P11946 | Other Identifier | INSYS Therapeutics Inc |
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Business decision by the sponsor during Phase 1.
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1- 1 μg/kg | Other | 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 |
|
| Part 1 - 2 μg/kg | Other | 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 |
|
| Part 1 - 3 μg/kg | Other | 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 |
|
| Part 2 - All Participants | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL-13-PE | Drug | IL-13-PE intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of IL-13-PE | during 16-week dose-escalation treatment, up to 3 years | |
| Best overall response | during 16-week treatment, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with clinically significant abnormal findings on physical examination | during 16-week treatment and 12-month follow-up, up to 4 years | |
| Percentage of participants with clinically significant abnormal findings on laboratory evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Progression-Free Survival | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Electron Kebebew, M.D. | National Institutes of Health (NIH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute at the National Institutes of Health | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22570059 | Background | 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. | |
| 18973179 | Background | 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. |
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| ID | Term |
|---|---|
| D018268 | Adrenocortical Carcinoma |
| D000310 | Adrenal Gland Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| during 16-week treatment and 12-month follow-up, up to 4 years |
| Indefinitely |
| 21386792 | Background | 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. |
| D009369 | Neoplasms |
| D000306 | Adrenal Cortex Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D000303 | Adrenal Cortex Diseases |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |