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

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
incomplete Freund's adjuvant
multi-epitope melanoma peptide vaccine
sargramostim
Sponsored by
Craig L Slingluff, Jr
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage II melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma

Eligibility Criteria

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

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

Sites / Locations

  • Washington Cancer Institute at Washington Hospital Center
  • Fox Chase Cancer Center
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute
  • MD Anderson Cancer Center at University of Texas
  • Cancer Center at the University of Virginia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 4, 2004
Last Updated
December 18, 2014
Sponsor
Craig L Slingluff, Jr
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00089193
Brief Title
Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
Official Title
Evaluation of GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization With Multiple Synthetic Melanoma Peptides
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Craig L Slingluff, Jr
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. 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.
Detailed Description
OBJECTIVES: Compare immune response in patients with stage IIB-IV melanoma treated with vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 with vs without sargramostim (GM-CSF). Compare immune response in patients treated with these vaccinations administered at 1 vs 2 sites. OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms. Arm I: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 1 injection site. Arm II: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 2 injection sites. Arm III: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) at 1 injection site. Arm IV: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF at 2 injection sites. In all arms, treatment repeats once weekly for 6 weeks. Patients return for booster vaccinations at weeks 12, 26, 39, and 52. PROJECTED ACCRUAL: A maximum of 124 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
Melanoma (Skin)
Keywords
stage II melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
incomplete Freund's adjuvant
Intervention Type
Biological
Intervention Name(s)
multi-epitope melanoma peptide vaccine
Intervention Type
Biological
Intervention Name(s)
sargramostim

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Washington Cancer Institute at Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Hillman Cancer Center at University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
MD Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Cancer Center at the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24377099
Citation
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.
Results Reference
derived

Learn more about this trial

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

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