Vemurafenib and White Blood Cell Therapy for Advanced Melanoma

Summary

Background:

\- One possible treatment for advanced melanoma involves collecting white blood cells from the person with cancer and growing them in a laboratory. The cells can then be given back to the donor. This study will use this white blood cell treatment with the cancer treatment drug vemurafenib. Vemurafenib targets melanoma cells that have a mutation in the B-raf gene, and may be able to make them shrink.

Objectives:

\- To see if vemurafenib and white blood cell therapy is a safe and effective treatment for advanced melanoma.

Eligibility:

\- Individuals at least 18 years and less than or equal to 66 years of age who have advanced melanoma that contains the B-raf genetic mutation.

Design:

* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
* White blood cells will be collected from tumor cells. These cells will be collected during surgery or a tumor biopsy.
* Participants will have leukapheresis to collect additional white blood cells for the procedure.
* Participants will take vemurafenib twice a day, starting 3 weeks before receiving the white blood cells.
* Participants will have 1 week of chemotherapy to prepare their immune system to accept the white blood cells.
* Participants will receive an infusion of their collected white blood cells. They will also receive aldesleukin for up to 5 days to boost the immune system s response to the white blood cells. They will remain in the hospital until they have recovered from the treatment.
* Participants will have frequent follow-up visits to monitor the outcome of the treatment.

Conditions

• Metastatic Cancer
• Melanoma

Interventions

DRUG

Vemurafenib

Vemurafenib will administered orally twice a day at a dose of 960 mg from day -21 (+/- 7 days)until disease progression or patients are taken off protocol.

BIOLOGICAL

Young TIL

Young TIL will be administered intravenously on day 0(1x10e9 to 2x10e11) in the Patient Care Unit over 20-30 minutes via non-filtered tubing, gently agitating the bag during infusion to prevent cell clumping.

DRUG

Cyclophosphamide

Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.

DRUG

Fludarabine

Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

DRUG

Aldesleukin

Aldeskeukin 720,000 IU/kg IV (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Steven A Rosenberg, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

66 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-09

Primary Completion

2016-07-21

Completion

2016-07-21

Countries

• United States

Study Locations