NCT00036816

Brief Summary

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

1 year

First QC Date

May 13, 2002

Last Update Submit

September 20, 2012

Conditions

Intraocular Melanoma

Keywords

ciliary body and choroid melanoma, medium/large size

Interventions

MART-1 antigenBIOLOGICAL
NA17-A antigenBIOLOGICAL
gp100 antigenBIOLOGICAL
tyrosinase peptideBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

University of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

MART-1 Antigen

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Intervention Hierarchy (Ancestors)

Melanoma-Specific AntigensNeoplasm ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigens, NeoplasmAntigensBiological Factors

Study Officials

  • Vincent Brichard, MD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    STUDY CHAIR

  • Jan U. Prause, MD

    University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2002

First Posted

January 27, 2003

Study Start

February 1, 2002

Primary Completion

February 1, 2003

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

BE(1)DK(1)