Drosophila-generated CTL

Summary

Background:

* Recent cancer treatment studies have shown that altering a cancer patient's own white blood cells may help the immune system fight the cancer. In all of these studies, participants donate their own white blood cells through a procedure called leukapheresis, and the cells are altered in the laboratory and given back to the participants. After the cells are given, the patients receive aldesleukin (IL-2) to help the tumor fighting cells stay alive longer. For individuals with metastatic melanoma, pieces of melanoma proteins may be added to the collected white blood cells to help the immune system recognize and attack the cancer cells.
* Researchers are interested in testing a new process in which cells from fruit flies (Drosophila) are used to help the melanoma proteins attach to the white blood cells. The fruit fly cells die off shortly after the proteins are introduced to the white blood cells. Researchers are also interested in determining whether IL-2 treatment is necessary after this new cancer treatment process.

Objectives:

* To test the safety and effectiveness of modified white blood cells (Drosophila-generated CTL) as a treatment for metastatic melanoma that has not responded to standard treatments.
* To determine whether IL-2 treatment improves the effectiveness of Drosophila-generated cytolytic T lymphocytes (CTL).

Eligibility:

\- Individuals at least 18 years of age who have been diagnosed with metastatic melanoma that has not responded to previous IL-2 treatment.

Design:

* Participants will be screened with a physical examination and medical history, tumor imaging studies, and heart and lung function tests.
* Prior to treatment, participants will have an intravenous catheter inserted into the chest to administer the study drugs.
* Participants will have leukapheresis to provide white blood cells for laboratory modification.
* Seven days before the start of the treatment, participants will be admitted to the hospital to have chemotherapy with cyclophosphamide and fludarabine. These drugs will suppress the immune system to improve the effects of the treatment.
* One to four days after the last dose of chemotherapy, participants will receive the modified cells. Participants in the group that will receive IL-2 will begin to receive the treatment 24 hours after the cell infusion, every day for 5 days. All participants will receive filgrastim injections to help the body produce more white blood cells.
* Participants will recover in the hospital for about 7 to 12 days after the cell infusion or the last dose of IL-2. Participants will continue to receive medications and provide blood and tumor samples for testing.
* Participants will have regular followup visits to assess the effects of the treatment.

Conditions

• Metastatic Cutaneous Melanoma

Interventions

DRUG

fludarabine

Fludarabine 25 mg/m\^2 x 5 days

DRUG

cyclophosphamide

Cyclophosphamide 60 mg/kg intravenous (IV) x 2 days

DRUG

Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL

Up to 1x10e10 CTL-05 cells

DRUG

Aldesleukin

Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• James Yang, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-15

Primary Completion

2011-12-08

Completion

2011-12-08

FDA Drug

Yes

Countries

• United States

Study Locations