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Treatment of Metastatic Melanoma With Tumor Infiltrating Lymphocytes and IL-2 Following Lympho-depleting Chemotherapy

Treatment of Metastatic Melanoma Patients With Tumor Infiltrating Lymphocytes and IL-2 Following a Regimen of Non-myeloablative Lymphocyte Depleting Chemotherapy

NCT00604136•Hadassah Medical Organization

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Summary

Prior preclinical and clinical studies have shown that tumors from patients with advanced melanoma contain tumor-infiltrating lymphocytes (TIL) with anti-tumor reactivity. These TIL can be expanded in the laboratory to large numbers, and reinfused to the patient. Using a chemotherapy regimen that selectively kills lymphocytes, a single institution Phase II study of 35 patients showed a 51% objective response rate to TIL and interleukin-2 injection. In the present trial we would like to investigate whether we can achieve similar results in a Hadassah Phase II study, and to determine the feasibility of applying this approach to patients with advanced melanoma who currently have few treatment options.

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. For HLA-A0201+ patients, lesions must be \> 1.5 cm in diameter and for HLA-A0201- patients, lesions must be \> 3 cm in diameter.
•Patients must be \> 18 years of age and must have measurable metastatic melanoma (in addition to the resected lesion).
•Patients of both genders must be willing to practice birth control during treatment and for four months after receiving the preparative regimen.
•Clinical performance status of ECOG 0, 1.
•Absolute neutrophil count greater than 1000/mm3 without support of filgrastim.
•Platelet count greater than 100,000/mm3.
•Serum 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.
•Patients must be able to understand and sign the Informed Consent document

Exclusion Criteria

•* Less than 4 weeks has elapsed since any prior systemic therapy or less than six weeks since prior nitrosourea therapy
•* Women who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
•* Life expectancy of less than three months.
•* Patients who have received prior treatment with 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 CNS lesions will not be eligible until after treatment of their symptomatic lesions.
•* Less than 4 weeks has elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, or less than six weeks since prior nitrosourea therapy. All patients' toxicities must have recovered to a grade 1 or less or as specified in the eligibility criteria. Patients may have undergone minor surgical procedures or focal palliative radiotherapy (to non-target lesions) within the past 4 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the eligibility criteria.
•* Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
•* Life expectancy of less than three months.
•* Requirement for systemic steroid therapy.
•* Hemoglobin less than 8g/dl unable to be corrected with transfusion.
+10 more criteria

Locations (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Key Dates

Start Date

July 1, 2008

Primary Completion Date

December 1, 2019

Completion Date

July 1, 2020

Last Updated

September 18, 2018

Enrollment

ESTIMATED participants

Conditions

Metastatic Melanoma

Interventions

tumor infiltrating lymphocytes

BIOLOGICAL

Contacts

Michal Lotem, MD

CONTACT

972508573528 mlotem@hadassah.org.il

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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 18, 2018Data 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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Treatment of Metastatic Melanoma With Tumor Infiltrating Lymphocytes and IL-2 Following Lympho-depleting Chemotherapy

Inclusion Criteria

Exclusion Criteria

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