Clinical trial NCT00089193: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma (Skin)
Keywords: stage II melanoma
stage III melanoma
stage IV melanoma
recurrent melanoma
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-08-05
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Cancer Institute at Washington Hospital Center
state: District of Columbia
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Hillman Cancer Center at University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center at University of Texas
state: Texas
city: Charlottesville
country: United States
facility: Cancer Center at the University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Craig L. Slingluff, MD
role: STUDY_CHAIR
References:
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.