Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed - Full Text View

Sponsor:	New York University School of Medicine
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00045383

Purpose

RATIONALE: Vaccines made from proteins may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase I/II trial is comparing two different vaccine therapies to see how well they work in treating patients with stage II or stage III melanoma that has been surgically removed.

Condition	Intervention	Phase
Melanoma (Skin)	Biological: dendritic cell vaccine therapy Biological: synthetic tumor-associated peptide vaccine therapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	A Randomized, Controlled Trial Of Melanoma Treatment: Comaprison Of Dendritic Cells Versus QS-21 As Adjuvants To Stimulate A-tumor Immunity

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Immunological response [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	April 2002
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC). PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin (KLH), flu matrix, and HLA A*0201-restricted melanoma antigens (Melan-A, MART-1, gp100 antigen, tyrosinase, MAGE-3, and NY-ESO-B) to elicit antigen-specific CD8+ T cells. One day after the DC are exposed to the antigens, patients receive a priming injection of melanoma antigen-pulsed mature DC vaccine subcutaneously (SC) on day 1 of week 1.	Biological: dendritic cell vaccine therapy Given subcutaneously
Arm II: Experimental Patients receive a priming injection of vaccine comprising KLH, flu matrix, and HLA A*0201-restricted melanoma antigens with QS21 adjuvant SC on day 1 of week 1.	Biological: synthetic tumor-associated peptide vaccine therapy Given subcutaneously

Arms

Assigned Interventions

Arm I: Experimental

Patients undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC). PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin (KLH), flu matrix, and HLA A*0201-restricted melanoma antigens (Melan-A, MART-1, gp100 antigen, tyrosinase, MAGE-3, and NY-ESO-B) to elicit antigen-specific CD8+ T cells. One day after the DC are exposed to the antigens, patients receive a priming injection of melanoma antigen-pulsed mature DC vaccine subcutaneously (SC) on day 1 of week 1.

Biological: dendritic cell vaccine therapy

Given subcutaneously

Arm II: Experimental

Patients receive a priming injection of vaccine comprising KLH, flu matrix, and HLA A*0201-restricted melanoma antigens with QS21 adjuvant SC on day 1 of week 1.

Biological: synthetic tumor-associated peptide vaccine therapy

Given subcutaneously

Detailed Description:

OBJECTIVES:

Compare the immunogenicity of vaccination with melanoma antigen-pulsed dendritic cells vs melanoma antigens with QS21 adjuvant in patients with surgically resected stage IIB, IIC, or III melanoma.
Compare the toxicity of these vaccinations in these patients.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC). PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin (KLH), flu matrix, and HLA A*0201-restricted melanoma antigens (Melan-A, MART-1, gp100 antigen, tyrosinase, MAGE-3, and NY-ESO-B) to elicit antigen-specific CD8+ T cells. One day after the DC are exposed to the antigens, patients receive a priming injection of melanoma antigen-pulsed mature DC vaccine subcutaneously (SC) on day 1 of week 1.
Arm II: Patients receive a priming injection of vaccine comprising KLH, flu matrix, and HLA A*0201-restricted melanoma antigens with QS21 adjuvant SC on day 1 of week 1.

In both arms, patients then receive 3 booster injections of vaccine (that dose not contain KLH) SC monthly (weeks 4, 8, and 12) for a total of 4 injections.

Patients are followed every 12 weeks.

PROJECTED ACCRUAL: A total of 50 patients (25 per treatment arm) will be accrued for this study within 1.5-3 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of stage IIB, IIC, or III melanoma that has been surgically resected
HLA-A0201 positive

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 80-100%

Life expectancy

Not specified

Hematopoietic

WBC at least 3,500/mm^3
Platelet count at least 125,000/mm^3
Hemoglobin at least 9 g/dL

Hepatic

Lactic dehydrogenase no greater than 2 times normal
Bilirubin no greater than 2 mg/dL
Albumin at least 3.5 mg/dL
No chronic active hepatitis

Renal

Creatinine no greater than 2 mg/dL

Other

HIV negative
No pre-existing retinal or choroidal eye disease
No allergy to shellfish
No allergy to gentamicin, tobramycin, streptomycin, or amikacin
No known autoimmune disease (e.g., systemic lupus erythematosus or rheumatoid arthritis) except vitiligo
No chronic infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior interferon alfa
No prior biologic therapy
No prior peptides used in this study, melanoma protein vaccine, melanoma whole cell vaccines, or QS21
No other concurrent biologic therapy

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No concurrent radiotherapy

Surgery

See Disease Characteristics
Recovered from prior surgery
No concurrent surgery

Other

No concurrent systemic therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045383

Locations

United States, New York
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Rockefeller University Hospital
New York, New York, United States, 10021-6399

Sponsors and Collaborators

New York University School of Medicine

National Cancer Institute (NCI)

Investigators

Study Chair:

Anna Pavlick, MD

New York University School of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	NYU Cancer Institute at New York University Medical Center ( Ralph Steinman )
Study ID Numbers:	CDR0000256890, NYU-RUH-NBH-0428-0401, RUH-NBH-0428-0401, NCI-5636
Study First Received:	September 6, 2002
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00045383 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II melanoma
stage III melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on November 27, 2009