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Vaccine Therapy In Treating Patients At High Risk For Recurrence Of Melanoma
This study is ongoing, but not recruiting participants.
First Received: June 5, 2003   Last Updated: February 6, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00062218
  Purpose

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

PURPOSE: This randomized phase II trial is studying how well vaccine therapy works in treating patients at high risk for recurrence of melanoma.


Condition Intervention Phase
Melanoma (Skin)
 Biological: MART-1 antigen
Biological: gp100 antigen
Biological: incomplete Freund's adjuvant
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Randomized Comparison Of Peptide Immunization In Patients At High Risk For Recurrence Of Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Freund's adjuvant
U.S. FDA Resources

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

Primary Outcome Measures:
  • Immunologic activity [ Designated as safety issue: No ]
  • Immune response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: May 2003
Estimated Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental

Patients receive MART-1:27-35 peptide emulsified with Montanide ISA-51 (ISA-51) subcutaneously (SC) on day 1 every 3 weeks for 4 doses (1 course).

Treatment repeats every 12 weeks for up to 4 courses.

 Biological: MART-1 antigen
Given subcutaneously
Biological: incomplete Freund's adjuvant
Given subcutaneously
Arm II: Experimental
Patients receive 27-35 (27L):MART-1 peptide emulsified with ISA-51 SC on day 1 every 3 weeks for 4 doses (1 course). Treatment repeats every 12 weeks for up to 4 courses.
Biological: MART-1 antigen
Given subcutaneously
Biological: incomplete Freund's adjuvant
Given subcutaneously
Arm III: Experimental
Patients receive MART-1:26-35 (27L) peptide emulsified with ISA-51 SC on day 1 every 3 weeks for 4 doses (1 course). Treatment repeats every 12 weeks for up to 4 courses.
Biological: MART-1 antigen
Given subcutaneously
Biological: incomplete Freund's adjuvant
Given subcutaneously
Arm VI: Experimental
Patients receive 27-35 (27L):MART-1 peptide and gp 100:209-217 (210M) antigen peptide emulsified with ISA-51 SC on day 1 every 3 weeks for 4 doses (1 course). Treatment repeats every 12 weeks for up to 4 courses.
Biological: MART-1 antigen
Given subcutaneously
Biological: gp100 antigen
Given subcutaneously
Biological: incomplete Freund's adjuvant
Given subcutaneously

Detailed Description:

OBJECTIVES:

  • Compare the immunologic activity of immunization with MART-1:27-35, 27-35 (27L):MART-1, or MART-1:26-35 (27L) peptide or 27-35 (27L):MART-1 peptide combined with gp100:209-217 (210M) antigen peptide, in terms of immune response in HLA-A*0201-positive patients at high risk for recurrence of melanoma.
  • Compare the response rate to treatment with interleukin-2 (IL-2) upon disease recurrence after immunization with the usual response rate to IL-2 in patients with metastatic melanoma.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive MART-1:27-35 peptide emulsified with Montanide ISA-51 (ISA-51) subcutaneously (SC) on day 1 every 3 weeks for a total of 4 doses (1 course).
  • Arm II: Patients receive 27-35 (27L):MART-1 peptide emulsified with ISA-51 SC on day 1 every 3 weeks for a total of 4 doses (1 course).
  • Arm III: Patients receive MART-1:26-35 (27L) peptide emulsified with ISA-51 SC on day 1 every 3 weeks for a total of 4 doses (1 course).
  • Arm IV: Patients receive 27-35 (27L):MART-1 peptide and gp 100:209-217 (210M) antigen peptide emulsified with ISA-51 SC on day 1 every 3 weeks for a total of 4 doses (1 course). In all arms, treatment repeats every 12 weeks for 4 courses in the absence of unacceptable toxicity or progressive disease. Patients with tumor recurrence during the first course with an easily resectable lesion undergo surgery to eradicate evidence of disease and continue with immunization.

Patients with disease progression, other than the preceding, do not receive further peptide administration and are considered for interleukin-2 (IL-2) therapy.

  • Interleukin-2 (IL-2) therapy: Patients receive IL-2 IV over 15 minutes every 8 hours for up to 4 days (maximum of 12 doses). Treatment repeats once after 10-14 days (1 course) in the absence of unacceptable toxicity. Patients with stable disease or a partial response are re-treated every 2 months.

Patients with stable disease may receive up to 2 courses of re-treatment. Patients who continue to respond receive re-treatment as long as the disease is regressing. A maximum of 1 re-treatment is given after a complete response. After 4 courses of IL-2, patients who show no evidence of stable or responding disease are removed from the study. Patients are followed every 3 months for 1 year and then every 6 months for 5 years or until disease progression.

PROJECTED ACCRUAL: A total of 76-132 patients (19-33 per treatment arm) will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of melanoma considered at high risk for recurrence with at least 1 of the following characteristics:

    • Lesions at least 1.5 mm in thickness*
    • At least 1 positive lymph node*
    • Ulcerated lesions*
    • Local recurrence*
    • Completely resected metastatic melanoma NOTE: *Within 6 months of surgical resection
  • HLA-A*0201 positive
  • Must be clinically disease free (by radiologic studies within 6 weeks of study entry)
  • No ocular or mucosal melanoma

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,000/mm^3
  • Platelet count at least 90,000/mm^3

Hepatic

  • Bilirubin no greater than 1.6 mg/dL (less than 3.0 mg/dL in patients with Gilbert's syndrome)
  • AST/ALT less than 3 times normal
  • Hepatitis B surface antigen negative

Renal

  • Creatinine no greater than 2.0 mg/dL

Immunologic

  • No active primary or secondary immunodeficiency
  • No known hypersensitivity to any study agents
  • No autoimmune disease
  • No active systemic infection
  • HIV negative

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 3 weeks since prior adjuvant immunotherapy (including interferon)
  • At least 3 weeks since prior biologic therapy for metastatic disease
  • No prior immunization with MART-1

Chemotherapy

  • At least 3 weeks since prior chemotherapy for metastatic disease and recovered

Endocrine therapy

  • No concurrent systemic steroid therapy

Radiotherapy

  • Recovered from prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • At least 3 weeks since prior systemic anticancer therapy except surgery and recovered from toxic effects other than those which have no clinical implications (e.g., vitiligo and alopecia)
  • No other concurrent systemic anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062218

Locations
United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
  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

Study ID Numbers: CDR0000304577, NCI-03-C-0172, NCI-6211
Study First Received: June 5, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00062218     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage III melanoma
stage IV melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Immunologic Factors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Adjuvants, Immunologic
Neuroepithelioma
 Freund's Adjuvant
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions
Melanoma
 Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Freund's Adjuvant

ClinicalTrials.gov processed this record on July 02, 2009



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