Possible New Therapy for Advanced Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adrenocortical Carcinoma

Intervention / Treatment
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* Drug: IL-13-PE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Part 1- 1 μg/kg<br>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<br>* IL-13-PE intravenous infusion<br>* Other names: Interleukin-13 PE38QQR;|
| Other: Part 1 - 2 μg/kg<br>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<br>* IL-13-PE intravenous infusion<br>* Other names: Interleukin-13 PE38QQR;|
| Other: Part 1 - 3 μg/kg<br>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<br>* IL-13-PE intravenous infusion<br>* Other names: Interleukin-13 PE38QQR;|
| Experimental: Part 2 - All Participants<br>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<br>* IL-13-PE intravenous infusion<br>* Other names: Interleukin-13 PE38QQR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | during 16-week treatment and 12-month follow-up, up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adrenal Gland Cancer, Treatment Refractory Malignancies, Metastatic Cancer