Possible New Therapy for Advanced Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | December 2012 |
| End Date: | December 2016 |
| Contact: | Roxanne Merkel, RN, OCD/CCR/NCI |
| Email: | merkelre@mail.nih.gov |
| Phone: | (301) 402-4395 |
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
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.
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.
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
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