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Possible New Therapy for Advanced Cancer

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ClinicalTrials.gov Identifier: NCT01832974
Recruitment Status : Terminated (Business decision by the sponsor during Phase 1.)
First Posted : April 16, 2013
Last Update Posted : April 27, 2015
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
INSYS Therapeutics Inc

September 11, 2012
April 16, 2013
April 27, 2015
December 2012
March 2014   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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 baseline sum longest diameter(SLD). All other lesions were identified as non-TLs and recorded at baseline. PD for TLs was defined as ≥ 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Patients with neither PD nor death were censored at the date of the last tumor assessment that confirmed no PD. Patients who underwent surgical resection with curative intent without prior progression were censored at the date of surgery.
Complete list of historical versions of study NCT01832974 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
  • Estimated Progression-Free Survival [ Time Frame: during 16-week treatment and 12-month follow-up, up to 4 years ]
  • Survival [ Time Frame: Indefinitely ]
    Following the 12-month follow-up evaluation patients will be followed via phone or e-mail contact every 6 months for survival
Not Provided
 
Possible New Therapy for Advanced Cancer
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Adrenocortical Carcinoma
Drug: IL-13-PE
IL-13-PE intravenous infusion
Other Name: Interleukin-13 PE38QQR
  • 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
    Intervention: Drug: IL-13-PE
  • 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
    Intervention: Drug: IL-13-PE
  • 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
    Intervention: Drug: IL-13-PE
  • Experimental: 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)
    Intervention: Drug: IL-13-PE

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
36
September 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01832974
13-C-0046
13-C-0046 D ( Other Identifier: National Institutes of Health Clinical Center )
P11946 ( Other Identifier: INSYS Therapeutics Inc )
Not Provided
Not Provided
Not Provided
INSYS Therapeutics Inc
INSYS Therapeutics Inc
National Institutes of Health (NIH)
Principal Investigator: Electron Kebebew, M.D. National Institutes of Health (NIH)
INSYS Therapeutics Inc
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP