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A Study Using Tumor-Reactive Autologous Tumor Infiltrating Lymphocytes (TIL) in Metastatic Melanomas | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study Using Tumor-Reactive Autologous Tumor Infiltrating Lymphocytes (TIL) in Metastatic Melanomas

A Phase II Study Using Tumor-Reactive Autologous Tumor Infiltrating Lymphocytes (TIL) Plus IL-2 Followed by Lymphocyte Depleting Chemotherapy Regimen in Metastatic Melanomas

NCT02375984•Saint John's Cancer Institute

View on ClinicalTrials.gov

Summary

The purpose of this protocol is to determine whether autologous TIL infused in conjunction with systemic high-dose IL-2 after non-myeloablative chemotherapy with cyclophosphamide and fludarabine can cause consistent and durable objective responses in patients who have metastatic melanoma at the John Wayne Cancer Institute (JWCI).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have metastatic melanoma with a resectable metastatic lesion of sufficient size and be willing to undergo such a resection for experimental purposes.
•Patients must be \> 18 years of age.
•Patients must have measurable disease measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (in addition to the resected lesion).
•Patients of child bearing potential must agree to use an effective form of birth control during study and up to four months after receiving treatment.
•Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
•Absolute neutrophil count greater than 1000/mm3 without support of filgrastim.
•Platelet count greater than 100,000/mm3.
•Serum Alanine transaminase/Aspartate transaminase (ALT/AST) less than three times the upper limit of normal.
•Serum creatinine less than or equal to 1.6 mg/dl.
•Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 mg/dl.
+1 more criteria

Exclusion Criteria

•All systemic, cytotoxic therapy (including targeted therapies) must be stopped at least 5 weeks prior to cell infusion (see 2.1.3).
•Women who are pregnant or breastfeeding.
•Life expectancy of less than three months.
•Patients who have received prior treatment with anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody will be excluded unless a post anti-CTLA-4 antibody treatment colonoscopy was normal with normal colonic biopsies.
•Patients who require immediate active treatment for symptomatic Central Nervous System (CNS) lesions will not be eligible until after treatment of their symptomatic lesions.
•Less than 5 weeks has elapsed since any prior systemic therapy at the time the patient receives the preparative regimen. All patients' toxicities must have recovered to a grade 1 or less or as specified in the eligibility criteria in Section 2.1.1. Patients may have undergone minor surgical procedures or focal palliative radiotherapy (to non-target lesions) within the past 5 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the eligibility criteria in Section 2.1.1.
•Women of child-bearing potential who are pregnant or breastfeeding.
•Life expectancy of less than three months.
•Systemic steroid therapy more than the equivalent of 10mg/day of prednisone.
•Hemoglobin less than 8g/dl unable to be corrected with transfusion.
+9 more criteria

Locations (1)

John Wayne Cancer Institute

Santa Monica, California, United States

Key Dates

Start Date

March 16, 2016

Primary Completion Date

June 1, 2017

Completion Date

June 1, 2017

Last Updated

September 22, 2021

Enrollment

ACTUAL participants

Conditions

Metastatic Melanoma

Interventions

Tumor Infiltrating Lymphocytes (TIL)

BIOLOGICAL

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Using Tumor-Reactive Autologous Tumor Infiltrating Lymphocytes (TIL) in Metastatic Melanomas

Inclusion Criteria

Exclusion Criteria

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