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

NCT00089219 | Completed Phase 1 DMC

• 3 other identifiers: 10464UVACC-MEL-41UVACC-28502
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Safety: Dose-limiting toxicity

  Toxicities measured by CTCAE.

  During study period

• Immunogenicity

  Melanoma peptide-specific helper T cell responses in the sentinel immunized node (SIN) on day 22.

  day 22

Secondary Outcomes (3)

• Immune response in the blood

  day 50

• DTH response

  by day 85

• Clinical outcome

  during the study

Study Arms (3)

Arm A. 6MHP vaccine 200 mcg

EXPERIMENTAL

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

Biological: IFA; Biological: 6MHP; Biological: GM-CSF

Arm B. 6MHP vaccine 400 mcg

EXPERIMENTAL

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

Biological: IFA; Biological: 6MHP; Biological: GM-CSF

Arm C. 6MHP vaccine 800 mcg

EXPERIMENTAL

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

Biological: IFA; Biological: 6MHP; Biological: GM-CSF

Interventions

IFA BIOLOGICAL

vaccine adjuvant

Also known as: incomplete Freund's adjuvant, Montanide ISA-51

Arm A. 6MHP vaccine 200 mcg; Arm B. 6MHP vaccine 400 mcg; Arm C. 6MHP vaccine 800 mcg

6MHP BIOLOGICAL

melanoma helper peptides

Also known as: multi-epitope melanoma peptide vaccine

Arm A. 6MHP vaccine 200 mcg; Arm B. 6MHP vaccine 400 mcg; Arm C. 6MHP vaccine 800 mcg

GM-CSF BIOLOGICAL

vaccine adjuvant

Also known as: sargramostim

Arm A. 6MHP vaccine 200 mcg; Arm B. 6MHP vaccine 400 mcg; Arm C. 6MHP vaccine 800 mcg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• University of Virginia: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Related Publications (3)

• 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.

  PMID: 18809608 RESULT

• 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.

  PMID: 28851380 DERIVED

• 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.

  PMID: 25126421 DERIVED

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

incomplete Freund's adjuvant; montanide ISA 51; Granulocyte-Macrophage Colony-Stimulating Factor; sargramostim

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Craig L. Slingluff, MD

  University of Virginia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: August 4, 2004
• First Posted: August 5, 2004
• Study Start: July 1, 2003
• Primary Completion: May 1, 2006
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

US (1)