Melanoma Treatment With White Blood Cells That Destroy MART Expressing Tumor Cells

Summary

Background:

\- Some cancer treatments collect a patient s own blood cells to use as specialized cancer-fighting cells. Collected white blood cells known as PBL (peripheral blood lymphocytes) can use to isolate special cells that can fight tumors. Before treatment with PBL, chemotherapy is given to destroy existing white blood cells so that the new cells can survive and attack the tumors. After PBL treatment, aldesleukin is given to help the new cells grow. Researchers want to see if special white blood cells that recognize a specific protein that is present in melanoma cells (melanoma antigen recognized by T cells (MART)) can cause tumors to shrink. These white blood cells will be tested with and without aldesleukin.

Objectives:

* To test the safety and effectiveness of white blood cells that target MART in the treatment of melanoma.
* To test white blood cells that target MART with and without aldesleukin.

Eligibility:

\- Individuals at least 18 years of age who have melanoma that has not responded to standard treatments.

Design:

* Participants will be screened with a medical history and physical exam. Blood and urine samples will be taken. Imaging studies such as x-rays or magnetic resonance imaging scans will be performed.
* Participants will provide white blood cells through leukapheresis. Researchers will attempt to isolate white blood cells that recognize MART
* Seven days before the start of treatment, participants will have chemotherapy.
* After the last dose of chemotherapy, participants will receive the MART reactive PBL cells. Filgrastim doses will also be given to help white blood cell counts return to normal. Participants will have frequent blood tests.
* Participants who are able to have aldesleukin treatment will start within 24 hours after receiving the MART reactive PBL cells. Treatment will continue for up to 5 days.
* Participants may have an optional tumor or lymph node biopsy to study the effects of treatment.
* If the tumor continues to grow after MART PBL treatment, participants may have one more round of cell collection and treatment.
* Participants will have followup visits for up to 6 months after receiving the MART reactive PBL treatment.

Conditions

• Metastatic Melanoma
• Skin Cancer

Interventions

DRUG

Fludarabine

25 mg/m\^2 IV (in the vein) for 5 days (day -5 to -1)

DRUG

Cyclophosphamide

60 mg/kg IV (in the vein) for days -7 and -6

DRUG

Aldesleukin

Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg intravenous (IV) over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6

DRUG

MART-1 Reactive CD8+ PBL

Intravenous (IV) over 30 minutes on day 0

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Udai S Kammula, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2014-02-28

Completion

2014-02-28

Countries

• United States

Study Locations