NIH Clinical Research Studies

Protocol Number: 00-C-0074

Active Accrual, Protocols Recruiting New Patients

Title:
Evaluation of Late Effects and Natural History of Disease in Patients Treated with Radiotherapy
Number:
00-C-0074
Summary:
This study will examine the effectiveness and side effects of an experimental vaccine to treat ocular metastatic melanoma. Melanoma tumors produce proteins called gp100 and MART-1. Vaccination with specific pieces of these proteins (peptides) may boost the immune system's fight against the cancer. The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the immune response to the peptide.

Patients 16 years of age and older with progressive metastatic ocular melanoma and for whom standard treatments no longer work may be eligible for this study. Candidates will be screened with a complete physical and examination, including an eye examination, blood and urine tests, chest X-ray, electrocardiogram, X-ray and nuclear medicine imaging scans to evaluate the size and extent of tumor, and, if needed, a cardiac stress test and lung function test. In addition, patients will be tested for their HLA tissue type; patients must be type HLA-A*0201, the type on which this vaccine is based.

Participants will receive two injections of both peptide vaccines (a total of four shots) in the thigh each week for 4 weeks. Some patients may undergo a biopsy -surgical removal of a small piece of tissue under local anesthetic-of normal skin and tumor or lymph node tissue to examine the effects of the vaccines on the tumor immune cells. Patients will also undergo plasmapheresis-a procedure to collect white blood cells-before treatment begins, after the second vaccination and 3 weeks after the fourth vaccination. For this procedure, blood is drawn through a needle in the arm, similar to donating blood. The blood goes through a machine that separates out the white cells (immune system cells), and the rest of the blood is returned through a needle in the other arm.

Patients return for follow-up 3 to 4 weeks after the fourth injection. Patients in whom disease has not progressed or whose tumor has shrunk may receive additional 4-week treatment courses for up to 6 courses (24 immunizations). Patients whose tumor has not responded to therapy and who are physically eligible to receive a substance called interleukin-2 (IL-2) may receive a second series of vaccines together with this agent. IL-2 may boost the immune response to the peptides. It is given intravenously (through a small tube placed in a vein) every 8 hours for 5 days after each vaccination. Patients who respond to the vaccine and IL-2 may be offered additional courses of this treatment regimen.

Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: Yes
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Radiation Oncology Branch investigator deems that it is in the best interests of the patient and the NCI/ROB for the patient to be seen in follow-up in the ROB clinic.

Patient or guardian is able to provide informed consent.

Patient must have a primary physician in the community to whom records and appropriate follow-up management can be given. Social services will be enlisted for any patients who lack health insurance, etc.

Patients who have received radiotherapy in the ROB and may or may not be officially entered on a clinical protocol. Some patients treated prior to 1993 may not have been officially entered on a clinical protocol.

EXCLUSION CRITERIA:

Patients who are on another active primary research protocol at NIH.

Special Instructions: Currently Not Provided
Keywords:
Follow-Up
Long-Term
Radiation
Side-Effects
Therapy
Recruitment Keywords:
None
Conditions:
Neoplasm
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
CSSC
Clinical Studies Support Center/NCI
164 Rollins Avenue
2nd FLoor
Rockville, MD 20852
Phone: (888) 624-1937
Fax: (301) 881-8239
Electronic Address: ncicssc@mail.nih.gov

Citations: Not Provided

Active Accrual, Protocols Recruiting New Patients

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