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Innovative Research and Clinical Trials

Many advances in the diagnosis and treatment of cancer patients have occurred because of pioneering research studies called “clinical trials.” Participation in innovative research and clinical trials is an important commitment of Hoag Cancer Center in its mission to provide the highest quality cancer treatment and management.

Hoag’s cancer research team is composed of physicians, scientists, nurses and other medical professionals who are committed to providing leading-edge care for cancer patients by providing access to nationally recognized clinical trials using new or unique treatments through research protocols.

The following are the disease-specific clinical trials currently being studied at Hoag Cancer Center. Please click on any of the following for details, or call the nursing management team at Hoag Clinical Trials at 949/764-5543.

Active clinical trials at Hoag Cancer Center (listed by disease):

Glioblastoma (Brain)
Melanoma

From left to right Hoag Clinical Trials nursing staff: Cristina de Leon, BSN, RN, CCRA; Cheryl Mayorga, LVN, CCRP; Carol DePriest, RN, OCN, CLNC, CCRC and Robin Ellis, BS, RN, CCRC.

For details about the groundbreaking research being conducted at Hoag Cell Biology Laboratory, click here. For more information about the importance of clinical trials, visit the National Cancer Institute (NCI) or National Institutes of Health (NIH) Websites.

Clinical trials available at Hoag Cancer Center:

Protocol: Brain LAK vs Gliadel® wafers for patients with Glioblastoma

Title: Randomized Phase II Trial of Intralesional Lymphokine Activated Killer Cells or Polifeprosan 20 with Carmustine Implant (Gliadel® Wafer) as Consolidation Therapy after Primary Treatment of Newly Diagnosed Resectable Glioblastoma

Principal Investigator: Robert Dillman, MD

Sponsor: Hoag Hospital

Description:
The purpose of this study is to determine how effective the study drug is in delaying a recurrence of a patient’s brain tumor and helping patients to live longer. Up to 80 patients with a diagnosis of glioblastoma (grade 4 anaplastic astrocytoma) may be enrolled in this trial. Half (about 40) of the patients will be randomized (selection of treatment by chance, like flipping a coin) to receive one of the following treatments, which will be placed in the brain at the time of surgery (craniotomy):
1) An experimental treatment, using Lymphokine Activated Killer (LAK) cells OR
2) FDA approved treatment, using implantable Gliadel® wafers
There is an equal chance of being assigned to either treatment group. There is no placebo (sugar or fake pill) used in this study.

This trial is an option for patients if they are:

18 years of age or older with newly diagnosed glioblastoma for which primary treatment consisting of surgery, radiation therapy, and temozolomide chemotherapy has been administered;
Willing to undergo a second brain surgery (craniotomy) at Hoag Hospital to place the study drug into the brain cavity (the neurosurgeon investigator involved in the study MUST feel that the second surgical procedure can be performed);
In good physical health;
Other eligibility criteria apply

The study agents, described below, will be given as part of the treatment plan that follows the initial therapy in those patients whose disease is felt to be under control.

LAK cells: A patient’s white blood cells are collected with a special machine (like donating blood) and treated outside the body with an immune-stimulating chemical called interleukin-2 (IL-2), which induces these cells to increase in number and increase their anticancer killing function. It is hoped that these cells placed into the area of the brain tumor will kill any residual tumor cells.

Gliadel® wafers: These are small, thin, dime-sized wafers that are absorbed by the body, and contain the cancer chemotherapeutic drug, carmustine (BCNU). Up to eight wafers can be implanted in the cavity where the tumor resided. Once implanted, Gliadel® wafers slowly dissolve, releasing high concentrations of chemotherapy into the tumor site.

The treatment is administered only at Hoag Hospital in Newport Beach, CA, and is not a treatment for patients who have recurrent brain cancer.

This protocol has been reviewed by Coast Independent Review Board, LLC and the U.S. Food and Drug Administration (FDA).

Trial listing updated: November 13, 2008

Contact Information: For more information, contact the Clinical Trials Office at 949.764.5543.

Name of Study: HCC 06-03: Randomized Phase II Trial of Autologous Vaccines Consisting of Adjuvant GM-CSF plus Proliferating Tumor Cells versus GM-CSF plus Dendritic Cells Loaded with Proliferating Tumor Cells in Patients with Metastatic Melanoma

Disease Type: Metastatic Melanoma, Stage 3 or 4

Abbreviated Name: MAC-VAC

Sponsor: Hoag Hospital

Principal Investigator: Robert Dillman, MD, FACP

Description: In this clinical trial, a patient’s own (‘autologous’) melanoma tumor tissue cells are grown in a laboratory, treated with radiation (so they cannot keep growing), and then given back to the patient in a series of 8 vaccinations. It is a randomized, open label study designed to determine whether 1 of 2 autologous vaccines have better patient outcomes; the study does not involve a placebo treatment. Eligible patients will be randomized to 1 of 2 tumor cell vaccines:

50% of patients will receive the Tumor Cell Vaccine. This vaccine consists of a patient’s own tumor cells that have been treated with radiation, and added to GM-CSF (an immune stimulating substance) for injection.
50% of patients will receive the Dendritic Cell Vaccine. This vaccine is the same as the Tumor Cell vaccine above, except that a patient’s own dendritic cells (specialized immune cells) have been added.

This trial is an option for patients at least 16 years of age with Stage 3 or 4 melanoma that can be eliminated by local treatment (e.g. surgery, radiation therapy, or radiosurgery). Such patients may have tissue removed and sent to Hoag Cancer Center for development of a tumor cell line by the Cell Biology Laboratory. A cell line can be established about 65% of the time, and the process of growing the tumor cells typically takes 2 to 10 months; so this is not a treatment that can be made available quickly. If successfully grown, and if patients consent to therapy and are otherwise eligible, patients are randomized to receive either vaccine. Dendritic Cell Vaccine patients undergo a procedure following randomization called ‘pheresis’, in which immune cells are obtained from the blood stream and converted into dendritic cells in the laboratory.

Vaccine Therapy: Vaccines are injected into the soft tissue of the skin (subcutaneously) once a week for 3 weeks, then once a month for up to 5 months (total of 6 months of treatment). Patients will receive a maximum of 8 vaccination doses. The treatment must be given at Hoag Hospital Cancer Center. This is not a treatment for patients who have growing brain metastases, or for patients with wide spread melanoma that is rapidly progressing despite other therapies. We plan to randomize 200 patients, with 100 in each autologous vaccine arm.

Patient Eligibility:

Karnofsky Performance Status (KPS) of 70 to 100%
No active central nervous system metastases at the time of randomization
No diagnosis of any other invasive cancer within the past five years
Age > 16 years and in satisfactory medical condition
No anticancer therapy for 3 weeks prior to randomization
No active infection or underlying cardiac disease
No known autoimmune disease
Serum pregnancy test must be negative for women of childbearing potential
Patients may have received any or all of the following: surgery, radiation therapy, chemotherapy, biotherapy, including GM-CSF, and prior vaccine therapy.
Other eligibility criteria apply

Coast Independent Review Board and the U.S. Food and Drug Administration have reviewed this protocol; it is also posted on the National Cancer Institute’s Clinical Trials Physician Data Query (PDQ).

Contact Information:

Hoag Cancer Center Clinical Trials Department
Phone: 949/764-5543
Fax: 949/764-8102

Trial listing dated: 04/11/07

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