Possible New Therapy for Advanced Cancer

Adrenocortical Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01832974
• Other study ID #: 13-C-0046
• Secondary ID: 13-C-0046 DP1194
• Status: Terminated
• Phase: Phase 1
• First received: September 11, 2012
• Last updated: April 24, 2015
• Start date: December 2012
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: INSYS Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Adrenocortical Carcinoma

Intervention

Drug:
• IL-13-PE
IL-13-PE intravenous infusion

Locations

Country	Name	City	State
United States	National Cancer Institute at the National Institutes of Health	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
INSYS Therapeutics Inc	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Fassnacht M, Libé 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Estimated Progression-Free Survival		during 16-week treatment and 12-month follow-up, up to 4 years	Yes
Other	Survival	Following the 12-month follow-up evaluation patients will be followed via phone or e-mail contact every 6 months for survival	Indefinitely	Yes
Primary	Maximum tolerated dose of IL-13-PE		during 16-week dose-escalation treatment, up to 3 years	Yes
Primary	Best overall response		during 16-week treatment, up to 3 years	No
Secondary	Percentage of participants with clinically significant abnormal findings on physical examination		during 16-week treatment and 12-month follow-up, up to 4 years	Yes
Secondary	Percentage of participants with clinically significant abnormal findings on laboratory evaluation		during 16-week treatment and 12-month follow-up, up to 4 years	Yes