Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma

NCT00089193 | Completed Phase 2 DMC

• 4 other identifiers: 10524UVACC-MEL-43FCCC-03045MDA-2003-0720
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells. PURPOSE: This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients with stage II B, stage IIC, stage III, or stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

stage II melanoma; stage III melanoma; stage IV melanoma; recurrent melanoma

Interventions

incomplete Freund's adjuvant BIOLOGICAL

multi-epitope melanoma peptide vaccine BIOLOGICAL

sargramostim BIOLOGICAL

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of melanoma * Stage IIB, IIC, III, or IV disease * Must express HLA-A1, -A2, or -A3 * No ocular melanoma PATIENT CHARACTERISTICS: Age * 12 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 * Not pregnant or nursing * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer without brain metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy * More than 4 weeks since prior growth factors * More than 4 weeks since prior allergy shots * No prior vaccine therapy for melanoma or any other cancer with any of the peptides used in this study * 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 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

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

Sponsors & Collaborators

• Craig L Slingluff, Jr: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MD Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Clancy-Thompson E, King LK, Nunnley LD, Mullins IM, Slingluff CL Jr, Mullins DW. Peptide vaccination in Montanide adjuvant induces and GM-CSF increases CXCR3 and cutaneous lymphocyte antigen expression by tumor antigen-specific CD8 T cells. Cancer Immunol Res. 2013 Nov;1(5):332-9. doi: 10.1158/2326-6066.CIR-13-0084.

  PMID: 24377099 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

incomplete Freund's adjuvant; sargramostim

Condition Hierarchy (Ancestors)

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

Study Officials

• Craig L. Slingluff, MD

  University of Virginia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Surgery

Study Record Dates

• First Submitted: August 4, 2004
• First Posted: August 5, 2004
• Study Start: September 1, 2003
• Primary Completion: February 1, 2007
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

US (5)