Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma
This study has been completed.
Sponsors and Collaborators: Norris Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031733
  Purpose

RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.


Condition Intervention Phase
Intraocular Melanoma
Melanoma (Skin)
Drug: MART-1 antigen
Drug: alum adjuvant
Drug: gp100 antigen
Drug: incomplete Freund's adjuvant
Drug: recombinant interleukin-12
Drug: sargramostim
Drug: tyrosinase peptide
Procedure: adjuvant therapy
Phase II

Genetics Home Reference related topics: retinoblastoma
MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor Tyrosinase Freund's adjuvant Montanide ISA 51 Interleukin-12 Alum, potassium Aluminum sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Phase II Randomized Trial of a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With Interleukin-12 With Alum or GM-CSF for Patients With Resected Stages IIB/C, III and IV Melanoma

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

Study Start Date: February 2002
Detailed Description:

OBJECTIVES:

  • Compare the immune reactivity in patients with resected stage IIB, IIC, III, or IV melanoma vaccinated with tyrosinase, gp100, and MART-1 peptides emulsified with Montanide ISA-51 with interleukin-12 and either alum adjuvant or sargramostim (GM-CSF).

OUTLINE: This is a randomized study. Patients are stratified according to disease stage (cutaneous stage IIB, IIC, III, and IV vs ocular and mucosal stage III and IV). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive vaccine with tyrosinase:368-376 (370D)/gp100:209-217 (210M)/MART-1:26-27 (27L) peptides emulsified with Montanide ISA-51 (ISA-51), low-dose interleukin-12 (IL-12) subcutaneously (SC), and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.
  • Arm II: Patients receive peptide vaccine emulsified with ISA-51, high-dose IL-12 SC, and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.
  • Arm III: Patients receive peptide vaccine emulsified with ISA-51 on day 1 and low-dose IL-12 SC and sargramostim (GM-CSF) SC on days 1-5 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 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, III, or IV cutaneous melanoma OR stage III or IV ocular or mucosal melanoma

    • Resected or rendered disease-free
  • HLA-A2.1-positive by standard cytotoxicity assay
  • Tumor tissue must be available for analysis of gp100 staining and tyrosinase and MART-1 expression by immunohistochemistry

    • Must be positive for at least 1 antigen
  • Failed, ineligible for, or refused prior interferon alfa

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL
  • No bleeding disorder

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • SGOT/SGPT no greater than 2.5 times normal
  • No coagulation disorder
  • Hepatitis surface antigen B negative
  • Hepatitis C negative

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No major cardiovascular illness

Pulmonary:

  • No major respiratory illness

Immunologic:

  • No prior uveitis
  • No prior autoimmune inflammatory eye disease
  • No immune hemolytic anemia
  • No other active autoimmune disease

Other:

  • HIV negative
  • No major gastrointestinal illness
  • No other malignancy within the past 5 years except squamous cell skin cancer or carcinoma in situ of the cervix curatively treated at least 30 days ago
  • No major systemic infection (e.g., pneumonia or sepsis)
  • No other major medical illness
  • No prior allergic reaction to Montanide ISA-51 or alum adjuvant
  • No requirement for steroid therapy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No prior tyrosinase:368-376 (370D), gp100:209-217 (210M), or MART-1:26-35 (27L) peptides

Chemotherapy:

  • At least 1 month since prior adjuvant chemotherapy for this disease
  • No concurrent adjuvant chemotherapy

Endocrine therapy:

  • No concurrent steroids

Radiotherapy:

  • At least 1 month since prior radiotherapy for this disease
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • At least 1 month since other prior therapy, including adjuvant therapy, for this disease
  • No other concurrent therapy, including adjuvant therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031733

Locations
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089
Sponsors and Collaborators
Norris Comprehensive Cancer Center
Investigators
Study Chair: Jeffrey S. Weber, MD, PhD Norris Comprehensive Cancer Center
  More Information

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

Study ID Numbers: CDR0000069220, LAC-USC-10M011, LAC-USC-IRB-013030, NCI-5506
Study First Received: March 8, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00031733  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
iris melanoma
ciliary body and choroid melanoma, small size
ciliary body and choroid melanoma, medium/large size
extraocular extension melanoma
recurrent intraocular melanoma
stage II melanoma
stage III melanoma
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Interleukin-12
Eye Neoplasms
Eye Diseases
Recurrence
Melanoma
Neuroendocrine Tumors
Melanoma of the choroid
Neuroectodermal Tumors
Uveal melanoma
Aluminum sulfate
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Intraocular melanoma
Neuroepithelioma
Freund's Adjuvant
Nevus

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Adjuvants, Immunologic
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Nevi and Melanomas
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009