Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma

NCT ID: NCT00003222

Last Updated: 2014-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-04-30

Brief Summary

RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to and kill tumor cells. Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in the bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with GM-CSF and interleukin-2 may be kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccines made from melanoma cells with or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV melanoma.

Detailed Description

OBJECTIVES: I. Compare the effectiveness of vaccination with synthetic melanoma peptides pulsed on autologous dendritic cells versus vaccination with synthetic melanoma peptides plus sargramostim (GM-CSF) in decreasing tumor burden in patients with high risk melanoma (pulsed autologous dendritic cell arm closed 1/8/2001). II. Determine whether these regimens result in increased tumor specific immune responses as measured in vitro and in vivo. III. Determine whether these regimens stimulate T-cell responses in these patients.

OUTLINE: This is an open label study. Patients are included in treatment arm II only (arm I closed 1/8/2001): Arm I: Patients undergo leukapheresis to collect dendritic cells. Patients receive a mixture of synthetic melanoma peptides (gp100 antigen, tyrosinase, and tetanus peptides) pulsed on autologous dendritic cells IV and subcutaneously (SC). Arm II: Patients receive a mixture of synthetic melanoma peptides (gp100 antigen, tyrosinase, and tetanus peptides) and sargramostim (GM-CSF) emulsified in Montanide ISA-51 SC and intradermally. Patients receive vaccination during weeks 0, 1, 2, 4, 5, and 6 for a total of 6 doses and interleukin-2 SC daily on days 7-49. Patients receive 3 additional vaccinations at different sites not involved with the tumor concurrently with the first 3 vaccinations. Patients are evaluated at 8 weeks, 12 weeks, 6 months, 12 months, and 24 months.

PROJECTED ACCRUAL: A total of 27-54 patients will be accrued for this study within 2 years.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peptides pulsed on dendritic cells

4 melanoma peptides pulsed on monocyte-derived dendritic cells

Group Type: EXPERIMENTAL

aldesleukin

Intervention Type: BIOLOGICAL

Systemic subcutaneous delivery of low-dose IL-2.

gp100 antigen

Intervention Type: BIOLOGICAL

incomplete Freund's adjuvant

Intervention Type: BIOLOGICAL

tetanus peptide melanoma vaccine

Intervention Type: BIOLOGICAL

tyrosinase peptide

Intervention Type: BIOLOGICAL

Peptides in GMCSF-in-adjuvant

4 melanoma peptides administered as an emulsion with GM-CSF and Montanide ISA-51 adjuvant.

Group Type: EXPERIMENTAL

aldesleukin

Intervention Type: BIOLOGICAL

Systemic subcutaneous delivery of low-dose IL-2.

gp100 antigen

Intervention Type: BIOLOGICAL

incomplete Freund's adjuvant

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

tetanus peptide melanoma vaccine

Intervention Type: BIOLOGICAL

tyrosinase peptide

Intervention Type: BIOLOGICAL

Interventions

aldesleukin

Systemic subcutaneous delivery of low-dose IL-2.

Intervention Type: BIOLOGICAL

gp100 antigen

Intervention Type: BIOLOGICAL

incomplete Freund's adjuvant

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

tetanus peptide melanoma vaccine

Intervention Type: BIOLOGICAL

tyrosinase peptide

Intervention Type: BIOLOGICAL

Other Intervention Names

Interleukin-2

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage III or IV melanoma gp100 positive tumor cells and/or tyrosinase positive tumor cells HLA type A1, A2, or A3 Measurable disease May have up to 3 brain metastases if all are less than 2 cm in diameter and are asymptomatic, and there is no mass effect or they have been treated successfully by surgical excision or by gamma knife radiation therapy

PATIENT CHARACTERISTICS: Age: 18 to 79 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) AST and ALT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class II, III, or IV heart disease Other: No known or suspected allergy to any component of the vaccine No medical condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior growth factors At least 3 months since prior agents with putative immunomodulating activity (except nonsteroidal antiinflammatory agents) At least 1 year since other prior melanoma vaccinations Chemotherapy: At least 3 months since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 3 months since prior corticosteroids No concurrent corticosteroids Radiotherapy: At least 3 months since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 3 months since other prior investigational drugs or therapy At least 3 months since prior allergy desensitization injections At least 14 days since completion of acute treatment for a serious infection No concurrent allergy desensitization injections

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Craig L Slingluff, Jr

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig L. Slingluff, MD

Role: STUDY_CHAIR

University of Virginia

Locations

Cancer Center at the University of Virginia

Charlottesville, Virginia, United States

Countries

United States

References

Slingluff CL Jr, Petroni GR, Yamshchikov GV, Barnd DL, Eastham S, Galavotti H, Patterson JW, Deacon DH, Hibbitts S, Teates D, Neese PY, Grosh WW, Chianese-Bullock KA, Woodson EM, Wiernasz CJ, Merrill P, Gibson J, Ross M, Engelhard VH. Clinical and immunologic results of a randomized phase II trial of vaccination using four melanoma peptides either administered in granulocyte-macrophage colony-stimulating factor in adjuvant or pulsed on dendritic cells. J Clin Oncol. 2003 Nov 1;21(21):4016-26. doi: 10.1200/JCO.2003.10.005.

Reference Type: RESULT

PMID: 14581425 (View on PubMed)

Other Identifiers

IRB-HSR 7621

Identifier Type: -

Identifier Source: secondary_id

NCI-G98-1389

Identifier Type: -

Identifier Source: secondary_id

7621

Identifier Type: -

Identifier Source: org_study_id