Possible New Therapy for Advanced Cancer
Adrenocortical Carcinoma
About this trial
This is an interventional basic science trial for Adrenocortical Carcinoma focused on measuring Adrenal Gland Cancer, Treatment Refractory Malignancies, Metastatic Cancer
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
Sites / Locations
- National Cancer Institute at the National Institutes of Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Experimental
Part 1- 1 μg/kg
Part 1 - 2 μg/kg
Part 1 - 3 μg/kg
Part 2 - All Participants
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
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
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
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)