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

NCT00003222 | Completed Phase 2 Results DMC

• 3 other identifiers: 7621IRB-HSR 7621NCI-G98-1389
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (3)

• Evaluation of Objective Clinical Response (CR/PR/SD)

  The primary end point for this trial was clinical response. This was assessed by measurement of assessable metastatic deposits by CT, MRI, or direct measure of cutaneous deposits. Baseline tumor measurements used for assessment of clinical response were those obtained most immediately before the first vaccine administration and within 6 weeks of protocol entry. Measurements were made and reviewed by a multidisciplinary team. The original protocol defined tumor response on the basis of changes in cross-sectional area calculated as the product of two perpendicular measures. However, since the initiation of this study, the Response Evaluation Criteria in Solid Tumors Group (RECIST) system was employed as the current standard for clinical trials, in which response is based on changes in maximum cross-sectional dimensions. Computed tomography scans of clinical responders were reviewed again by a senior faculty radiologist not otherwise involved in the study.

  Weeks 0-6,12; Months 6,12 and 24

• Measure of Tumor-antigen-specific Immunity in Peripheral Blood Mononuclear Cells (PBMC) by Elispot Assay

  Weeks 0-6,12; Months 6,12 and 24

• Measure of Tumor-antigen-specific Immunity in Sentinel Immunized Node (SIN) by Elispot Assay

  Weeks 0-6,12; Months 6,12 and 24

Study Arms (2)

Peptides pulsed on dendritic cells

EXPERIMENTAL

4 melanoma peptides pulsed on monocyte-derived dendritic cells

Biological: aldesleukin; Biological: gp100 antigen; Biological: incomplete Freund's adjuvant; Biological: tetanus peptide melanoma vaccine; Biological: tyrosinase peptide

Peptides in GMCSF-in-adjuvant

EXPERIMENTAL

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

Biological: aldesleukin; Biological: gp100 antigen; Biological: incomplete Freund's adjuvant; Biological: sargramostim; Biological: tetanus peptide melanoma vaccine; Biological: tyrosinase peptide

Interventions

aldesleukin BIOLOGICAL

Systemic subcutaneous delivery of low-dose IL-2.

Also known as: Interleukin-2

Peptides in GMCSF-in-adjuvant; Peptides pulsed on dendritic cells

gp100 antigen BIOLOGICAL

Peptides in GMCSF-in-adjuvant; Peptides pulsed on dendritic cells

incomplete Freund's adjuvant BIOLOGICAL

Peptides in GMCSF-in-adjuvant; Peptides pulsed on dendritic cells

sargramostim BIOLOGICAL

Peptides in GMCSF-in-adjuvant

tetanus peptide melanoma vaccine BIOLOGICAL

Peptides in GMCSF-in-adjuvant; Peptides pulsed on dendritic cells

tyrosinase peptide BIOLOGICAL

Peptides in GMCSF-in-adjuvant; Peptides pulsed on dendritic cells

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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)

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• 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.

  PMID: 14581425 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; Interleukin-2; 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

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Results Point of Contact

• Title: Craig L. Slingluff, MD
• Organization: University of Virginia

CLS8H@hscmail.mcc.virginia.edu

434-924-1730

Study Officials

• Craig L. Slingluff, MD

  University of Virginia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: February 9, 2004
• Study Start: April 1, 1998
• Primary Completion: September 1, 2003
• Last Updated: December 19, 2014
• Results First Posted: December 19, 2014

Record last verified: 2014-12

Locations

US (1)