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

Hadassah Medical Organization1 site in 1 country20 target enrollmentJuly 2008

ConditionsMetastatic Melanoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Metastatic Melanoma
Sponsor: Hadassah Medical Organization
Enrollment: 20
Locations: 1
Primary Endpoint: To determine the response rate of this approach when administered in our hospital
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

July 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hadassah Medical Organization

Eligibility Criteria

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,
•Absolute neutrophil count greater than 1000/mm3 without support of filgrastim.
•Platelet count greater than 100,000/mm
•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

•Tumor/TIL Harvest 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.
•Cell Infusion Exclusion Criteria:
•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.