Possible New Therapy for Advanced Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-09-30

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.

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Detailed Description

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Conditions

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Adrenocortical Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part 1- 1 μg/kg

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

Group Type OTHER

IL-13-PE

Intervention Type DRUG

IL-13-PE intravenous infusion

Part 1 - 2 μg/kg

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

Group Type OTHER

IL-13-PE

Intervention Type DRUG

IL-13-PE intravenous infusion

Part 1 - 3 μg/kg

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

Group Type OTHER

IL-13-PE

Intervention Type DRUG

IL-13-PE intravenous infusion

Part 2 - All Participants

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)

Group Type EXPERIMENTAL

IL-13-PE

Intervention Type DRUG

IL-13-PE intravenous infusion

Interventions

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IL-13-PE

IL-13-PE intravenous infusion

Intervention Type DRUG

Other Intervention Names

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Interleukin-13 PE38QQR

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No