Condition or disease | Intervention/treatment | Phase |
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Metastatic Melanoma Locally Advanced Refractory/Recurrent Melanoma Metastatic Head and Neck Cancer Locally Advanced Refractory/Recurrent Head and Neck Cancer | Biological: Autologous Tumor Infiltrating Lymphocytes Biological: High-Dose Interleukin 2 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Trial of Lymphodepletion Followed by Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors |
Actual Study Start Date : | October 7, 2020 |
Estimated Primary Completion Date : | August 2022 |
Estimated Study Completion Date : | August 2023 |
Arm | Intervention/treatment |
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Experimental: melanoma |
Biological: Autologous Tumor Infiltrating Lymphocytes
Autologous TILs
Biological: High-Dose Interleukin 2 720,000 IU/kg every 8 hours for up to 15 doses
|
Experimental: head and neck cancer |
Biological: Autologous Tumor Infiltrating Lymphocytes
Autologous TILs
Biological: High-Dose Interleukin 2 720,000 IU/kg every 8 hours for up to 15 doses
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Progressive squamous cell cancer of the head and neck or metastatic melanoma since prior systemic treatment and who are:
Exclusion Criteria:
Contact: Gregory Daniels, MD, PhD | 858-534-3804 | gdaniels@ucsd.edu | |
Contact: Yael Cohen-Arazi | ycohenarazi@ucsd.edu |
United States, California | |
UC San Diego Moores Cancer Center | Recruiting |
La Jolla, California, United States, 92093 |
Principal Investigator: | Gregory Daniels, MD, PhD | University of California, San Diego | |
Principal Investigator: | Ezra Cohen, MD | University of California, San Diego |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 10, 2019 | ||||||||
First Posted Date ICMJE | June 19, 2019 | ||||||||
Last Update Posted Date | October 19, 2020 | ||||||||
Actual Study Start Date ICMJE | October 7, 2020 | ||||||||
Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Dose Limiting Toxicity [ Time Frame: 2 months ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors | ||||||||
Official Title ICMJE | Phase I Trial of Lymphodepletion Followed by Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors | ||||||||
Brief Summary | To determine whether special tumor fighting cells that is taken from participants' tumors and grown in the laboratory and then given back to the participant will fight the participant's cancer when their immune system is suppressed from attacking these special tumor fighting cells. This is called transfer of autologous (they came from you) tumor infiltrating lymphocytes (the cells that have been grown in the laboratory. Participants getting these cell infusions will also be treated with interleukin-2 (IL-2). | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
24 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | August 2023 | ||||||||
Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03991741 | ||||||||
Other Study ID Numbers ICMJE | 160710 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Gregory Daniels, University of California, San Diego | ||||||||
Study Sponsor ICMJE | Gregory Daniels | ||||||||
Collaborators ICMJE | Immunotherapy Foundation | ||||||||
Investigators ICMJE |
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PRS Account | University of California, San Diego | ||||||||
Verification Date | October 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |