Tumor-Infiltrating Lymphocytes And Low-Dose Interleukin-2 Therapy Following Cyclophosphamide And Fludarabine In Patients With Melanoma

NCT01883323 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-11-08

No results posted yet for this study

Summary

This is a phase II clinical study for patients with metastatic (the cancer has spread to other parts of the body) melanoma. Patients will receive an infusion (given by vein) of autologous tumor infiltrating lymphocytes (TILs). TILs are a type of white blood cells that recognizes tumor cells and enter them which causes the tumor cells to break down.

Prior to the cell infusion, patients will receive a two drugs cyclophosphamide and fludarabine to prepare the body to receive the TILs. After cell infusion, patients will receive low-dose interleukin-2 therapy which is an approved drug to treat melanoma. This study will see how useful this regimen is in treating metastatic melanoma.

Conditions

Metastatic, Stage III or Stage IV, Melanoma

Interventions

DRUG

Cyclophosphamide

i.v., 60mg/kg per day for 2 days

DRUG

Fludarabine

i.v., 25mg/m2 per day for 5 days

BIOLOGICAL

Tumor-Infiltrating Lymphocytes

i.v., 1x10\^10 - 1.6x10\^11 cells

BIOLOGICAL

Low-Dose Interleukin

i.v., 125,000 IU/kg subcut per day, for 2 weeks (2 days rest between each week)

Sponsors & Collaborators

University Health Network, Toronto
lead OTHER

Principal Investigators

Butler Marcus, M.D. · Princess Margaret Cancer Centre

Study Design

Allocation: NA
Purpose: TREATMENT
Masking: NONE
Model: SINGLE_GROUP

Eligibility

Min Age: 18 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2013-06-30
Primary Completion: 2018-04-30
Completion: 2018-04-30

Countries

Canada

Study Locations

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Entities

Drugs