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Trial record 23 of 147 for:    visilizumab

IMCgp100 in Advanced Unresectable Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01209676
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE September 22, 2010
First Posted Date  ICMJE September 27, 2010
Last Update Posted Date November 15, 2016
Study Start Date  ICMJE September 2010
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 15 months ]
To determine the safety and pharmacodynamic properties of single intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma. Tumor Lesions, peripheral blood pre- and post-injection will be used to determine the safety and pharmacodynamic properties of single intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2010)
Adverse Events as a Measure of Safety and Tolerability
To determin the safety and pharmacodynamic properties of single intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma. Tumor Lesions, peripheral blood pre- and post-injection will be used to determine the safety and pharmacodynamic properties of single intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma
Change History Complete list of historical versions of study NCT01209676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
  • Adverse events [ Time Frame: 15 months ]
    Will be used to determine the safety and tolerability of IMCgp100 at subtherapeutic doses.
  • Vital signs [ Time Frame: 15 months ]
    will be used to determine the safety and tolerability of IMCgp100 at subtherapeutic doses.
  • PE examinations findings [ Time Frame: 15 months ]
    will be used to determine the safety and tolerability of IMCgp 100 at subtherapeutic doses.
  • Peripheral blood samples [ Time Frame: 15 months ]
    will be used to examine peripheral cytokine measurements as evidence of product immunoactivity and peripheral T and NK cell numbers, phenotype and activation marker status.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2010)
  • Adverse events
    Will be used to determine the safety and tolerability of IMCgp100 at subtherapeutic doses.
  • Vital signs
    will be used to determin the safety and tolerabiluty of IMCgp100 at subtherapeutic doses.
  • PE examinations findings
    will be used to determin the safety and tolerability of IMCgp 100 at subtherapeutic doses.
  • Periperal blood samples
    will be used to examine peripheral cytokine measurements as evidence of product immunoactivity and peripheral T and NK cell numbers, phenotype and activation marker status.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IMCgp100 in Advanced Unresectable Melanoma
Official Title  ICMJE A Phase 0, Exploratory Study of the Pharmacodynamics of a Single Intratumoral Dose of IMCgp100, a Monoclonal Receptor Anti-CD3 scFv Fusion Protein, in Subjects With Advanced Unresectable Melanoma
Brief Summary A phase 0, exploratory study of the pharmacodynamics of a single intratumoral dose of IMCgp100, a monoclonal T cell receptor anti-CD3 scFv fusion protein, in subjects with advanced unresectable melanoma to assess the safety and pharmacodynamic properties of single intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma. Six patients will be enrolled to complete the study over approximately 12-15 months.
Detailed Description

This study will test the safety effect of a single dose of the investigational drug IMCgp100 when administered directly into the metastatic melanoma lesion in patients with advanced metastatic melanoma. IMCgp100 is a drug made up of two components. The first is the T cell receptor designed to bind specifically and tightly with protein found at high levels on the surface of melanoma cancer cells and second is an anti-CD3 fragment that is meant to bind to and activate the T cells. There will be two stage dose regimens each enrolling 3 patients. Stage 1 dose will 0.00017 mg IMCgp100 and Stage 2 dose will be 0.0017 mg IMCgp100. Inclusion Criteria: 1. Histologically confirmed dx of advanced unresectable melanoma not requiring immediate treatment and/or in a window between treatments 2. Two or more cutaneous or subcutaneous melanoma metastatic lesions 7 to 15 mm in at least one dimension and amenable to subsequent biopsy 3. Greater or equal to 18 years of age 4. ECOG PS 0-2 5.

Able to provide informed consent and willing to comply with protocol requirements 6. Female patients must not be of childbearing potential or must have negative serum pregnancy test 48 hours prior to receiving investigational drug 7. Male patients must agree to use reliable form of birth control throughout study 8. Must have adequate organ system function Exclusion Criteria: 1. Received any other chemo, immune, radiation or investigational therapy agents within 2 weeks prior to study treatment 2. Cutaneous metastasis that have received prior local therapy 3. Pregnant or breastfeeding 4.

History of autoimmune disease 5. Current treatment with steroid or other immunosuppressive meds 6. Active uncontrolled infection 7. Known HIV infection 8. Uncontrolled seizures 9. Known delayed wound healing 10. On full dose anticoagulation therapy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Advanced Disease
  • Unresectable
Intervention  ICMJE Drug: IMCgp100 injection
a monoclonal T cell receptor anti-CD3scFv fusion protein
Study Arms  ICMJE Experimental: IMCgp100
IMCgp100 will be injected cutaneously or subcutaneously into the metastasis, and peritumoral area if applicable
Intervention: Drug: IMCgp100 injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2016)
1
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2010)
20
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Histologically confirmed diagnosis of melanoma, with advanced unresectable disease not currently requiring immediate treatment and/or in a window between treatments.
  • 2. Two or more cutaneous or subcutaneous melanoma metastatic lesions 7-15 mm in at least one dimension and amenable to subsequent biopsy.
  • 3. Age 18 years
  • 4. ECOG performance status 0-2
  • 5. Able to understand and to provide written informed consent and willingness to comply with all protocol requirements;
  • 6. Female patients who are not be of childbearing potential as documented by medical history (e.g., tubal ligation or hysterectomy), or be post menopausal with a minimum 1 year without menses or have a negative serum beta human chorionic gonadotropin (HGC) pregnancy test within 48 hours prior to receiving the intratumoral injection and agree to use an acceptable form of birth control, defined as abstinence or use of an intrauterine device (IUD), oral contraceptive, barrier and spermicide, or hormonal implant throughout the study period;
  • 7. Male patients who must agree to use an acceptable form of birth control throughout the study period.
  • 8. Adequate organ system function as evidenced by laboratory values: -Absolute neutrophil count (ANC) greater than or equal to 1.0 X 109/L -Hemoglobin greater than or equal to 9 g/dL -Platelets greater than or equal to 75 X 109/L -Total bilirubin less than or equal to 1.5 mg/dL -AST and ALT less than or equal to 2.5 X ULN ( 2.5 X ULN in the presence of liver metastasis.) -Creatinine less than or equal to 2 mg/dL -TSH within normal limits -INR/PT and PTT less than or equal to 1.3 X ULN

Exclusion Criteria:

  • 1. Receive any chemotherapy, immunotherapy, radiation therapy, or other investigational agents (agents part of a research protocol or not approved by the FDA) within 2 weeks prior to injection. A minimum of 14 days is required between last therapy and injection on this study. In addition, any clinically significant drug-related toxicity should have recovered to grade 1 or less (excluding alopecia)
  • 2. Patients without cutaneous or subcutaneous metastatic lesions;
  • 3. Cutaneous metastases that have received prior local therapy, such as radiation or isolated limb perfusion.
  • 4. Pregnancy or breastfeeding
  • 5. History of autoimmune disease (excluding vitiligo or controlled thyroid disease) or immunodeficiency.
  • 6. Current treatment with steroids (inhaled, topical or systemic) or other immunosuppressive medications within 2 weeks of injection;
  • 7. Active uncontrolled infection;
  • 8. Known HIV positivity;
  • 9. Uncontrollable seizures;
  • 10. Known delayed wound healing;
  • 11. Full dose anticoagulation with heparin, warfarin, or any other anticoagulant within 2 weeks of injection ;
  • 12. History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting, stroke or TIA within the past 24 weeks.;
  • 13. Known hypersensitivity of IMCgp100 or any of its components (ie, Tween) ;
  • 14. Class II, III, or IV heart failure as defined by the New York Heart Association;
  • 15. Any psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • 16. Any other condition that in the investigators opinion would jeopardize compliance with the protocol ;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01209676
Other Study ID Numbers  ICMJE UPCC 03610
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giorgos Karakousis, MD Abramson Cancer Center of the University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date November 2016

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