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Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma

Primary Purpose

Intraocular Melanoma, Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IFA
6MHP
GM-CSF
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraocular Melanoma focused on measuring stage III melanoma, stage IV melanoma, recurrent melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent intraocular melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of stage IIIB, IIIC, or IV melanoma HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive Brain metastases allowed at the discretion of the principle investigator PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count > 1,000/mm^3 Platelet count > 100,000/mm ^3 Hemoglobin > 9 g/dL Hepatic Liver function tests ≤ 2.5 times upper limit of normal (ULN) Renal Creatinine ≤ 1.5 times ULN Cardiovascular No New York Heart Association class III or IV heart disease Other Prior diagnosis of other cancer allowed Not pregnant or nursing Weight ≥ 110 pounds No uncontrolled diabetes PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior growth factors More than 4 weeks since prior allergy shots More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine No prior vaccination with any of the peptides used in this study Chemotherapy More than 4 weeks since prior chemotherapy Endocrine therapy More than 4 weeks since prior steroids Radiotherapy More than 4 weeks since prior radiotherapy Surgery Not specified Other More than 1 month since prior investigational drugs or therapies No other concurrent investigational drugs or therapies

Sites / Locations

  • University of Virginia Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A. 6MHP vaccine 200 mcg

Arm B. 6MHP vaccine 400 mcg

Arm C. 6MHP vaccine 800 mcg

Arm Description

vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)

vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)

vaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)

Outcomes

Primary Outcome Measures

Safety: Dose-limiting toxicity
Toxicities measured by CTCAE.
Immunogenicity
Melanoma peptide-specific helper T cell responses in the sentinel immunized node (SIN) on day 22.

Secondary Outcome Measures

Immune response in the blood
Immune response measured in the blood, by proliferation assay, over time during the study.
DTH response
Delayed-type hypersensitivity response to tumor peptides
Clinical outcome
Clinical tumor response

Full Information

First Posted
August 4, 2004
Last Updated
November 18, 2014
Sponsor
University of Virginia
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00089219
Brief Title
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma
Official Title
Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.
Detailed Description
OBJECTIVES: Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF). OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43. Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I. Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I. On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine. PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Melanoma, Melanoma (Skin)
Keywords
stage III melanoma, stage IV melanoma, recurrent melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent intraocular melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A. 6MHP vaccine 200 mcg
Arm Type
Experimental
Arm Description
vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Arm Title
Arm B. 6MHP vaccine 400 mcg
Arm Type
Experimental
Arm Description
vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Arm Title
Arm C. 6MHP vaccine 800 mcg
Arm Type
Experimental
Arm Description
vaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Intervention Type
Biological
Intervention Name(s)
IFA
Other Intervention Name(s)
incomplete Freund's adjuvant, Montanide ISA-51
Intervention Description
vaccine adjuvant
Intervention Type
Biological
Intervention Name(s)
6MHP
Other Intervention Name(s)
multi-epitope melanoma peptide vaccine
Intervention Description
melanoma helper peptides
Intervention Type
Biological
Intervention Name(s)
GM-CSF
Other Intervention Name(s)
sargramostim
Intervention Description
vaccine adjuvant
Primary Outcome Measure Information:
Title
Safety: Dose-limiting toxicity
Description
Toxicities measured by CTCAE.
Time Frame
During study period
Title
Immunogenicity
Description
Melanoma peptide-specific helper T cell responses in the sentinel immunized node (SIN) on day 22.
Time Frame
day 22
Secondary Outcome Measure Information:
Title
Immune response in the blood
Description
Immune response measured in the blood, by proliferation assay, over time during the study.
Time Frame
day 50
Title
DTH response
Description
Delayed-type hypersensitivity response to tumor peptides
Time Frame
by day 85
Title
Clinical outcome
Description
Clinical tumor response
Time Frame
during the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of stage IIIB, IIIC, or IV melanoma HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive Brain metastases allowed at the discretion of the principle investigator PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count > 1,000/mm^3 Platelet count > 100,000/mm ^3 Hemoglobin > 9 g/dL Hepatic Liver function tests ≤ 2.5 times upper limit of normal (ULN) Renal Creatinine ≤ 1.5 times ULN Cardiovascular No New York Heart Association class III or IV heart disease Other Prior diagnosis of other cancer allowed Not pregnant or nursing Weight ≥ 110 pounds No uncontrolled diabetes PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior growth factors More than 4 weeks since prior allergy shots More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine No prior vaccination with any of the peptides used in this study Chemotherapy More than 4 weeks since prior chemotherapy Endocrine therapy More than 4 weeks since prior steroids Radiotherapy More than 4 weeks since prior radiotherapy Surgery Not specified Other More than 1 month since prior investigational drugs or therapies No other concurrent investigational drugs or therapies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig L. Slingluff, MD
Organizational Affiliation
University of Virginia
Official's Role
Study Chair
Facility Information:
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18809608
Citation
Slingluff CL Jr, Petroni GR, Olson W, Czarkowski A, Grosh WW, Smolkin M, Chianese-Bullock KA, Neese PY, Deacon DH, Nail C, Merrill P, Fink R, Patterson JW, Rehm PK. Helper T-cell responses and clinical activity of a melanoma vaccine with multiple peptides from MAGE and melanocytic differentiation antigens. J Clin Oncol. 2008 Oct 20;26(30):4973-80. doi: 10.1200/JCO.2008.17.3161. Epub 2008 Sep 22.
Results Reference
result
PubMed Identifier
28851380
Citation
Shukla GS, Olson WC, Pero SC, Sun YJ, Carman CL, Slingluff CL Jr, Krag DN. Vaccine-draining lymph nodes of cancer patients for generating anti-cancer antibodies. J Transl Med. 2017 Aug 29;15(1):180. doi: 10.1186/s12967-017-1283-8.
Results Reference
derived
PubMed Identifier
25126421
Citation
Dillon PM, Olson WC, Czarkowski A, Petroni GR, Smolkin M, Grosh WW, Chianese-Bullock KA, Deacon DH, Slingluff CL Jr. A melanoma helper peptide vaccine increases Th1 cytokine production by leukocytes in peripheral blood and immunized lymph nodes. J Immunother Cancer. 2014 Jul 15;2:23. doi: 10.1186/2051-1426-2-23. eCollection 2014.
Results Reference
derived

Learn more about this trial

Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma

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