Vaccine Therapy in Treating Patients With Melanoma of the Eye
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Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells and decrease the recurrence of melanoma of the eye.
PURPOSE: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who are at high risk for recurrent melanoma of the eye.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma |
Biological: MART-1 antigen Biological: NA17-A antigen Biological: gp100 antigen Biological: tyrosinase peptide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Randomized Phase III Study Of Adjuvant Immunization With The NA17.A2 And Melanoma Differentiation Peptites In HLA-A2 Patients With Primary Ocular Melanoma At High Risk Of Relapse |
| Enrollment: | 13 |
| Study Start Date: | February 2002 |
| Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine whether adjuvant NA17-A and melanoma differentiation peptides are effective in decreasing the occurrence of liver metastasis in HLA-A2-positive patients with primary ocular melanoma at high risk of relapse.
- Determine whether this regimen increases survival of these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor size (medium vs large), prior treatment of primary tumor (surgery vs radiotherapy), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive vaccination with NA17-A and melanoma differentiation peptides (e.g., tyrosinase, Melan-A, and gp100 antigens) subcutaneously and intradermally on days 1, 8, 15, and 22. Patients then receive a vaccination once every 14 days for 4 doses, once every 28 days for 4 doses, once every 56 days for 4 doses, and then once every 3 months for a total of 4 years.
- Arm II: Patients undergo observation only every 3 months for 2 years and then every 6 months for 2 years.
All patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of ocular melanoma
- No melanoma of the iris
Disease adequately treated by prior surgery (enucleation or tumorectomy) and/or radiotherapy
- No more than 5 weeks since the beginning of primary tumor treatment
Measurable disease
- At least 12.0 mm in largest diameter OR
- At least 6.0 mm in height
- HLA-A2 positive
- No distant metastases
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Hemoglobin at least 9 g/dL
- Neutrophil count at least 2,000/mm^3
- Lymphocyte count at least 700/mm^3
- Platelet count at least 100,000/mm^3
- No bleeding disorder
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- AST and ALT no greater than 2 times upper limit of normal (ULN)
- Lactate dehydrogenase no greater than 2 times ULN
- Alkaline phosphatase no greater than 2 times ULN
- Gamma glutamyl transpeptidases no greater than 2 times ULN
- Hepatitis C antibody negative
- Hepatitis B antigen negative
Renal:
- Creatinine no greater than 2.0 mg/dL
Immunologic:
- No clinical immunodeficiency
- No autoimmune diseases
- No inflammatory bowel disease
- No active infection requiring antibiotics
- No multiple sclerosis
Other:
- HIV negative
- No other malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
- No other uncontrolled illness
- No psychological, familial, sociological, or geographical conditions that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No other concurrent immunotherapy or biologic therapy
Chemotherapy:
- No concurrent chemotherapy
Endocrine therapy:
- At least 3 weeks since prior steroids
- No concurrent chronic therapy with high doses of corticosteroids (e.g., methylprednisolone at least 12 mg/day)
- Concurrent topical or inhalation steroids allowed
- No concurrent hormonal therapy
Radiotherapy:
- See Disease Characteristics
- Prior proton beam therapy allowed
- Prior brachytherapy without tumor resection allowed
- Recovered from prior radiotherapy
- No prior radiotherapy to the spleen
- No prior pre-enucleation radiotherapy
- No prior ruthenium Ru 106 as primary therapy alone
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Prior transcleral tumor resection allowed
- Recovered from prior surgery
- No prior major organ allograft
- No prior splenectomy
Other:
- No other concurrent investigational drugs
- No concurrent systemic immunosuppressive drugs
Contacts and Locations| Belgium | |
| Cliniques Universitaires Saint-Luc | |
| Brussels, Belgium, 1200 | |
| Denmark | |
| University of Copenhagen | |
| Copenhagen, Denmark, 2100 | |
| Study Chair: | Vincent Brichard, MD | Cliniques universitaires Saint-Luc |
| Study Chair: | Jan U. Prause, MD | University of Copenhagen |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00036816 History of Changes |
| Other Study ID Numbers: | EORTC-18001 -88001, EORTC-18001, EORTC-88001 |
| Study First Received: | May 13, 2002 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
ciliary body and choroid melanoma, medium/large size |
Additional relevant MeSH terms:
|
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013