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Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed
This study has been completed.
Study NCT00045383   Information provided by National Cancer Institute (NCI)
First Received: September 6, 2002   Last Updated: July 23, 2009   History of Changes

September 6, 2002
July 23, 2009
April 2002
June 2009   (final data collection date for primary outcome measure)
  • Immunological response [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Immunological response
  • Toxicity
Complete list of historical versions of study NCT00045383 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed
A Randomized, Controlled Trial Of Melanoma Treatment: Comaprison Of Dendritic Cells Versus QS-21 As Adjuvants To Stimulate A-tumor Immunity

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.

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.

Phase I, Phase II
Interventional
Treatment, Randomized, Open Label, Active Control
Melanoma (Skin)
  • Biological: dendritic cell vaccine therapy
  • Biological: synthetic tumor-associated peptide vaccine therapy
  • 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.
  • 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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
50
 
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00045383
Ralph Steinman, NYU Cancer Institute at New York University Medical Center
CDR0000256890, NYU-RUH-NBH-0428-0401, RUH-NBH-0428-0401, NCI-5636
New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Anna Pavlick, MD New York University School of Medicine
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP