Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Vaccine Therapy With or Without Montanide ISA-51 and/or Imiquimod in Treating Patients With Melanoma That Has Been Removed By Surgery

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	16 and over	NCI	NCI-06-C-0069 7676, NCI-7676, NCI-P6703, NCT00304057

Special Category: NIH Clinical Center trial

Objectives

1. Evaluate the immunologic activity of immunization with 4 different preparations of the gp100:209-217(210M) melanoma antigen peptide (comprising montanide ISA-51 VG and/or imiquimod) and potentially select one for further study in patients with resected high-risk melanoma.

Entry Criteria

Disease Characteristics:

• Diagnosis of primary melanoma meeting any of the following criteria:
  • Ulcerated lesions ≥ 2 mm
  • Any lesion ≥ 4.0 mm in thickness
  • At least 1 positive lymph node
  • Local recurrence
  • Metastatic disease



• Disease surgically resected within the past 6 months



• Clinically disease free by radiography within 6 weeks prior to study entry



• HLA-A* 0201 positive



• No ocular or mucosal melanoma

Prior/Concurrent Therapy:

• See Disease Characteristics
• At least 3 weeks since prior systemic anticancer therapy, including adjuvant immunotherapy (e.g., interferon)
• Recovered from prior therapy (vitiligo or alopecia allowed)
  • Recovered immune competence after prior radiotherapy
• No prior immunization with gp100 antigen
• No prior chemotherapy for treatment of melanoma
• No concurrent systemic steroid therapy
• No other concurrent systemic anticancer therapy

Patient Characteristics:

• ECOG performance status 0 or 1
• Creatinine ≤ 2.0 mg/dL
• Bilirubin ≤ 1.6 mg/dL (3.0 mg/dL for Gilbert's syndrome)
• WBC ≥ 3,000/mm³
• Platelet count ≥ 90,000/mm³
• AST/ALT < 3 times normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active systemic infections, autoimmune disease (e.g., autoimmune colitis or Crohn's disease), or any known immunodeficiency disease
• No known positivity for hepatitis B surface antigen or HIV antibody
• No known hypersensitivity to any agents used in this study

Expected Enrollment

A total of 145 patients will be accrued for this study.

Outcomes

Immunologic activity

Outline

This is a randomized study. Patients are randomized to 1 of 6 treatment arms (treatment arms I-IV closed to accrual as of 1/11/08).

• Arm I (closed to accrual as of 1/11/08): Patients receive immunization with gp100:209-217(210M) peptide emulsified in Montanide ISA-51 VG subcutaneously on day 1.



• Arm II (closed to accrual as of 1/11/08): Patients receive immunization as in arm I (closed to accrual as of 1/11/08). After injection, patients also apply imiquimod at the site of injection once daily on days 1-5.



• Arm III (closed to accrual as of 1/11/08): Patients receive immunization with gp100:209-217(210M) peptide mixed in sodium chloride intradermally on day 1.



• Arm IV (closed to accrual as of 1/11/08): Patients receive immunization as in arm III (closed to accrual as of 1/11/08). After injection, patients apply imiquimod at the site of injection once daily on days 1-5.



• Arm V: Patients receive immunization with gp100:209-217(210M) peptide emulsified using a 3-way stopcock with 2 syringes in Montanide ISA-51 VG subcutaneously on day 1.



• Arm VI: Patients receive immunization as in arm V. After injection, patients apply imiquimod at the site of once daily on days 1-5.

In all arms, treatment repeats every 21 days for 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for 1 year and then annually for 5 years.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Steven Rosenberg, MD, PhD, Protocol chair		Ph: 866-820-4505 Email: sar@nih.gov

U.S.A.
Maryland
	Bethesda
	NCI - Surgery Branch
		Steven Rosenberg, MD, PhD	Ph:  866-820-4505
			Email: sar@nih.gov
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Related Information

Web site for additional information

Registry Information
Official Title		Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High Risk Melanoma
Trial Start Date		2006-01-06
Trial Completion Date		2006-09-10 (estimated)
Registered in ClinicalTrials.gov		NCT00304057
Date Submitted to PDQ		2006-01-03
Information Last Verified		2008-11-30

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