Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Virginia National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00705640 |
RATIONALE: Vaccine therapy may help the body build an effective immune response to kill tumor cells.
PURPOSE: This randomized clinical trial is studying how well vaccine therapy works in treating patients with advanced melanoma.
Condition | Intervention |
---|---|
Intraocular Melanoma Malignant Conjunctival Neoplasm Melanoma (Skin) |
Biological: incomplete Freund's adjuvant Biological: multi-epitope melanoma peptide vaccine Biological: tetanus toxoid helper peptide Procedure: biopsy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Multipeptide Vaccine in Melanoma Patients With Evaluation of the Injection Site Microenvironment |
Estimated Enrollment: | 48 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1A: Experimental
Patients receive primary vaccine, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Patients receive no replicate vaccine. Patients undergo surgical biopsy at replicate vaccine site on day 1.
|
Biological: incomplete Freund's adjuvant
Given subcutaneously and intradermally
Biological: multi-epitope melanoma peptide vaccine
Given subcutaneously and intradermally
Biological: tetanus toxoid helper peptide
Given subcutaneously and intradermally
Procedure: biopsy
Patients undergo surgical biopsy at replicate vaccine site
|
Arm 1B: Experimental
Patients receive primary vaccine, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Patients receive replicate vaccine comprising incomplete Freund's adjuvant only SC and ID on day 1 and undergo surgical biopsy at replicate vaccine site on day 8 (1 week after replicate vaccine 1).
|
Biological: incomplete Freund's adjuvant
Given subcutaneously and intradermally
Biological: multi-epitope melanoma peptide vaccine
Given subcutaneously and intradermally
Biological: tetanus toxoid helper peptide
Given subcutaneously and intradermally
Procedure: biopsy
Patients undergo surgical biopsy at replicate vaccine site
|
Arm 1C: Experimental
Patients receive primary vaccine, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Patients receive replicate vaccine comprising incomplete Freund's adjuvant only SC and ID on days 1, 8, and 15 and undergo surgical biopsy at replicate vaccine site on day 22 (1 week after replicate vaccine 3).
|
Biological: incomplete Freund's adjuvant
Given subcutaneously and intradermally
Biological: multi-epitope melanoma peptide vaccine
Given subcutaneously and intradermally
Biological: tetanus toxoid helper peptide
Given subcutaneously and intradermally
Procedure: biopsy
Patients undergo surgical biopsy at replicate vaccine site
|
Arm 1D: Experimental
Patients receive primary vaccine, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Patients receive replicate vaccine comprising incomplete Freund's adjuvant only SC and ID on days 1, 8, 15, 29, 36, and 43 and undergo surgical biopsy at replicate vaccine site on day 50 (1 week after replicate vaccine 6). Patients are evaluated 1-3 weeks after biopsy.
|
Biological: incomplete Freund's adjuvant
Given subcutaneously and intradermally
Biological: multi-epitope melanoma peptide vaccine
Given subcutaneously and intradermally
Biological: tetanus toxoid helper peptide
Given subcutaneously and intradermally
Procedure: biopsy
Patients undergo surgical biopsy at replicate vaccine site
|
Arm 1E: Experimental
Patients receive primary vaccine, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Patients receive replicate vaccine comprising incomplete Freund's adjuvant only SC and ID on days 1, 8, 15, 29, 36, and 43 and undergo surgical biopsy at replicate vaccine site on day 85 (6 week after replicate vaccine 6). Patients are evaluated 1-3 weeks after biopsy.
|
Biological: incomplete Freund's adjuvant
Given subcutaneously and intradermally
Biological: multi-epitope melanoma peptide vaccine
Given subcutaneously and intradermally
Biological: tetanus toxoid helper peptide
Given subcutaneously and intradermally
Procedure: biopsy
Patients undergo surgical biopsy at replicate vaccine site
|
Arm 2A: Experimental
Patients receive primary vaccine, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Patients receive no replicate vaccine. Patients undergo surgical biopsy at replicate vaccine site on day 1.
|
Biological: incomplete Freund's adjuvant
Given subcutaneously and intradermally
Biological: multi-epitope melanoma peptide vaccine
Given subcutaneously and intradermally
Biological: tetanus toxoid helper peptide
Given subcutaneously and intradermally
Procedure: biopsy
Patients undergo surgical biopsy at replicate vaccine site
|
Arm 2B: Experimental
Patients receive primary vaccine, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Patients receive replicate vaccine (the same as primary vaccine) SC and ID on day 1 and undergo surgical biopsy at replicate vaccine site on day 8 (1 week after replicate vaccine 1).
|
Biological: incomplete Freund's adjuvant
Given subcutaneously and intradermally
Biological: multi-epitope melanoma peptide vaccine
Given subcutaneously and intradermally
Biological: tetanus toxoid helper peptide
Given subcutaneously and intradermally
Procedure: biopsy
Patients undergo surgical biopsy at replicate vaccine site
|
Arm 2C: Experimental
Patients receive primary vaccine, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Patients receive replicate vaccine (the same as primary vaccine) SC and ID on days 1, 8, and 15 and undergo surgical biopsy at replicate vaccine site on day 22 (1 week after replicate vaccine 3).
|
Biological: incomplete Freund's adjuvant
Given subcutaneously and intradermally
Biological: multi-epitope melanoma peptide vaccine
Given subcutaneously and intradermally
Biological: tetanus toxoid helper peptide
Given subcutaneously and intradermally
Procedure: biopsy
Patients undergo surgical biopsy at replicate vaccine site
|
Arm 2D: Experimental
Patients receive primary vaccine, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Patients receive replicate vaccine (the same as primary vaccine) SC and ID on days 1, 8, 15, 29, 36, and 43 and undergo surgical biopsy at replicate vaccine site on day 50 (1 week after replicate vaccine 6). Patients are evaluated 1-3 weeks after biopsy.
|
Biological: incomplete Freund's adjuvant
Given subcutaneously and intradermally
Biological: multi-epitope melanoma peptide vaccine
Given subcutaneously and intradermally
Biological: tetanus toxoid helper peptide
Given subcutaneously and intradermally
Procedure: biopsy
Patients undergo surgical biopsy at replicate vaccine site
|
Arm 2E: Experimental
Patients receive primary vaccine, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Patients receive replicate vaccine (the same as primary vaccine) SC and ID on days 1, 8, 15, 29, 36, and 43 and undergo surgical biopsy at replicate vaccine site on day 85 (1 week after replicate vaccine 6). Patients are evaluated 1-3 weeks after biopsy.
|
Biological: incomplete Freund's adjuvant
Given subcutaneously and intradermally
Biological: multi-epitope melanoma peptide vaccine
Given subcutaneously and intradermally
Biological: tetanus toxoid helper peptide
Given subcutaneously and intradermally
Procedure: biopsy
Patients undergo surgical biopsy at replicate vaccine site
|
OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 10 arms.
All patients receive primary vaccine comprising melanoma multipeptides and tetanus toxoid helper peptide emulsified in incomplete Freund's adjuvant, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Vaccines are administered in a single skin location on an extremity clinically uninvolved with melanoma. A replicate vaccine site is identified for each patient for skin biopsy with or with out replica vaccine administration.
Tissue biopsies are examined by reverse transcriptase-PCR, IHC, protein analysis, flow cytometry, and western blot. Blood samples are collected periodically and examined by ELIspot assay, tetramer staining, and proliferation assay.
After completion of study therapy, patients are followed annually.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed melanoma that meets one of the following criteria:
Brain metastases allowed if all of the following criteria are met:
Prior lymph node biopsy allowed if lymphoscintigraphy demonstrates intact drainage to a node in that basin
Either eligible for, but refused interferon therapy OR not a candidate for interferon therapy for the following reasons:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior and no concurrent use of any of the following:
Inhaled steroids (e.g., fluticasone propionate [Advair® or Flovent®] or triamcinolone acetonide [Azmacort®])
United States, Virginia | |
University of Virginia Cancer Center | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Craig L. Slingluff, MD 434-243-2611 cls8h@virginia.edu |
Principal Investigator: | Craig L. Slingluff, MD | University of Virginia |
Responsible Party: | University of Virginia Cancer Center ( Craig L. Slingluff, Jr ) |
Study ID Numbers: | CDR0000597922, UVACC-MEL-48, UVACC-IRB-13498, UVACC-PRC-450-07 |
Study First Received: | June 25, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00705640 History of Changes |
Health Authority: | Unspecified |
stage II melanoma stage III melanoma stage IV melanoma ciliary body and choroid melanoma, medium/large size ciliary body and choroid melanoma, small size |
conjunctival melanoma extraocular extension melanoma iris melanoma metastatic intraocular melanoma recurrent intraocular melanoma |
Immunologic Factors Eye Neoplasms Uveal Melanoma Eye Diseases Adjuvants, Immunologic Melanoma of the Choroid Recurrence Conjunctival Diseases Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular Melanoma Neuroepithelioma Freund's Adjuvant Nevus Conjunctival Neoplasms |
Neoplasms by Histologic Type Immunologic Factors Eye Neoplasms Eye Diseases Physiological Effects of Drugs Neoplasms, Nerve Tissue Adjuvants, Immunologic Pharmacologic Actions Conjunctival Diseases |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Freund's Adjuvant Nevi and Melanomas Conjunctival Neoplasms |