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Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma
This study has been completed.

First Received on March 8, 2002.   Last Updated on February 6, 2009   History of Changes
Sponsor: USC/Norris Comprehensive Cancer Center
Collaborator: 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)
Biological: MART-1 antigen
Biological: gp100 antigen
Biological: incomplete Freund's adjuvant
Biological: recombinant interleukin-12
Biological: sargramostim
Biological: tyrosinase peptide
Drug: alum adjuvant
Procedure: adjuvant therapy
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
USC/Norris Comprehensive Cancer Center
Investigators
Study Chair: Jeffrey S. Weber, MD, PhD USC/Norris Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00031733     History of Changes
Other Study ID Numbers: CDR0000069220, LAC-USC-10M011, LAC-USC-IRB-013030, NCI-5506
Study First Received: March 8, 2002
Last Updated: February 6, 2009
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

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Adjuvants, Immunologic
Aluminum Hydroxide
Aluminum sulfate
Freund's Adjuvant
Interleukin-12
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012