Chemotherapy Followed by Infusion of DMF5 Cells to Treat Metastatic Melanoma

Summary

Background:

* This study will use cells called DMF5 to treat patients with metastatic melanoma (melanoma that has spread beyond the primary tumor site).
* The DMF5 cells were first obtained from a tumor of a patient with melanoma with HLA-A201 tissue type. The tumor cells were grown in the laboratory, and when the laboratory-grown cells were given back to the patient, the patient's tumors shrank dramatically. In laboratory tests, DMF5 cells were also shown to shrink mouse melanoma tumors.

Objectives:

-To determine whether preparatory chemotherapy followed by infusion of DMF5 cells is a safe and effective for shrinking melanoma tumors.

Eligibility:

-Patients with metastatic melanoma and tissue type HLA-A201 who are 18 years of age or older.

Design:

* Patients have a preparatory regimen of chemotherapy with cyclophosphamide and fludarabine followed by infusion of DMF5 cells and then high-dose interleukin. The chemotherapy, interleukin and cells are given intravenously (through a vein).
* Patients have frequent blood tests to look for the side effects and response to treatment.
* Patients may be asked to have a tumor biopsy (surgical removal of a small piece of tumor tissue) to examine the effects of treatment on the immune cells in the tumor.
* Patients have a physical examination, computed tomography (CT) of the chest, abdomen and pelvis and laboratory tests 4 to 6 weeks after treatment and then monthly to evaluate the tumor.
* The first group of patients participates in the Phase I portion of the study, called the dose escalation phase. This phase will determine the highest safe dose of DMF5 cells. There will be three dose levels of DMF5 cells, with the first patients enrolled getting the smallest dose and then increasing the dose when the preceding level has been shown to be safe.
* Patients in the Phase II portion of the study receive DMF5 cells at the highest dose found to be safe in Phase I, to test the effectiveness of the treatment.

Conditions

• Melanoma
• Malignant Melanoma
• Melanoma, Experimental

Interventions

DRUG

DMF5 Melanoma Reactive TIL

given intravenously over 20-30 minutes (between 1 x 10\^9 and 1 x 10\^11 lymphocytes) after expansion in interleukin-2 and OKT-3

DRUG

Cyclophosphamide

60 mg/kg/day x 2 days intravenously

DRUG

Fludarabine

25 mg/m\^2/day intravenously x 5 days

DRUG

Aldesleukin

720,000 IU/kg/dose intravenously every 8 hours for up to 15 doses

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Steven Rosenberg, M.D. · National Cancer Institute, National Institutes of Health

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-08-31

Primary Completion

2010-10-31

Completion

2010-10-31

Countries

• United States

Study Locations