Possible New Therapy for Advanced Cancer

NCT01832974 | Terminated Phase 1

• 3 other identifiers: 13-C-004613-C-0046 DP11946
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adrenocortical Carcinoma

Keywords

Adrenal Gland Cancer; Treatment Refractory Malignancies; Metastatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Other Outcomes (2)

• Estimated Progression-Free Survival

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

• Survival

  Indefinitely

Study Arms (4)

Part 1- 1 μg/kg

OTHER

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

Part 1 - 2 μg/kg

OTHER

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

Part 1 - 3 μg/kg

OTHER

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

Part 2 - All Participants

EXPERIMENTAL

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

Interventions

IL-13-PE DRUG

IL-13-PE intravenous infusion

Also known as: Interleukin-13 PE38QQR

Part 1 - 2 μg/kg; Part 1 - 3 μg/kg; Part 1- 1 μg/kg; Part 2 - All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• INSYS Therapeutics Inc: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

National Cancer Institute at the National Institutes of Health

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 22570059 BACKGROUND

• 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.

  PMID: 18973179 BACKGROUND

• Fassnacht M, Libe 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.

  PMID: 21386792 BACKGROUND

MeSH Terms

Conditions

Adrenocortical Carcinoma; Adrenal Gland Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adrenal Cortex Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Electron Kebebew, M.D.

  National Institutes of Health (NIH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: April 16, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 27, 2015

Record last verified: 2015-04

Locations

US (1)