Clinical Trial: Possible New Therapy for Advanced Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 problem

Detailed Summary:
Sponsor: INSYS Therapeutics Inc

Current Primary Outcome:

  • Maximum tolerated dose of IL-13-PE [ Time Frame: during 16-week dose-escalation treatment, up to 3 years ]
  • Best overall response [ Time Frame: during 16-week treatment, up to 3 years ]


Original Primary Outcome:

  • Maximum tolerated dose in Phase 1 of the study [ Time Frame: Phase 1 of the study (up to 5 days) ]
  • Percentage of participants with an objective response (OR) [ Time Frame: Phase 2 of the study (up to 24 weeks) ]
    An OR=a complete (CR) or partial response (PR)/non-CR. All measurable lesions up to a maximum of 5 (maximum of 2/organ) representative of all involved organs will be identified as target lesions (TL) and measured at baseline. A sum of the diameters (SD, longest for non-nodal lesions, short axis for nodal lesions) for all TLs will be calculated and reported as the baseline SD. All other lesions including pathological lymph nodes (LN) will be identified as non-TLs and recorded, but not measured, at baseline. For TLs, CR=disappearance of all TLs and a reduction in the short axis to < 10 mm of any pathological LNs (whether target or non-target), and PR= ≥ 30% decrease in the SD of TLs taking as reference the baseline SD. For non-TLs, CR=disappearance of all non-TLs, normalization of tumor marker level (TML), and all LNs must be non-pathological in size (< 10 mm short axis); and non-CR=the persistence of 1 or more non-TLs and/or maintenance of TML above normal limits.
  • Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Phase 2 of the study (up to 24 weeks) ]
    PFS was defined as the time from randomization to disease progression (PD) or death. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the

    Current Secondary Outcome:

    • Percentage of participants with clinically significant abnormal findings on physical examination [ Time Frame: during 16-week treatment and 12-month follow-up, up to 4 years ]
    • Percentage of participants with clinically significant abnormal findings on laboratory evaluation [ Time Frame: during 16-week treatment and 12-month follow-up, up to 4 years ]


    Original Secondary Outcome:

    Information By: INSYS Therapeutics Inc

    Dates:
    Date Received: September 11, 2012
    Date Started: December 2012
    Date Completion:
    Last Updated: April 24, 2015
    Last Verified: April 2015