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

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00304057

Purpose

RATIONALE: Vaccines made from gp100 peptides may help the body build an effective immune response to kill tumor cells. Substances like Montanide ISA-51 and imiquimod help stimulate the immune system. Giving the vaccine together with Montanide ISA-51 and/or imiquimod after surgery may make a stronger immune response to kill any remaining tumor cells and prevent or delay the recurrence of melanoma.

PURPOSE: This randomized phase II trial is studying how well vaccine therapy works together with or without Montanide ISA 51 and/or imiquimod in treating patients with melanoma that has been removed by surgery.

Condition	Intervention	Phase
Melanoma (Skin)	Drug: gp100 antigen Drug: imiquimod Drug: incomplete Freund's adjuvant	Phase II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: S 26308 Freund's adjuvant Montanide ISA 51

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High Risk Melanoma

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

Primary Outcome Measures:

Immunologic activity [ Designated as safety issue: No ]

Estimated Enrollment:	145
Study Start Date:	January 2006
Estimated Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I (closed to accrual as of 1/11/08): Experimental Patients receive immunization with gp100:209-217(210M) peptide emulsified in Montanide ISA-51 VG subcutaneously on day 1.	Drug: gp100 antigen Given subcutaneously Drug: incomplete Freund's adjuvant Given subcutaneously
Arm II (closed to accrual as of 1/11/08): Experimental 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.	Drug: gp100 antigen Given subcutaneously Drug: imiquimod Applied at the site of injection Drug: incomplete Freund's adjuvant Given subcutaneously
Arm III (closed to accrual as of 1/11/08): Experimental Patients receive immunization with gp100:209-217(210M) peptide mixed in sodium chloride intradermally on day 1.	Drug: gp100 antigen Given subcutaneously
Arm IV (closed to accrual as of 1/11/08): Experimental 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.	Drug: gp100 antigen Given subcutaneously Drug: imiquimod Applied at the site of injection
Arm V: Experimental 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.	Drug: gp100 antigen Given subcutaneously Drug: incomplete Freund's adjuvant Given subcutaneously
Arm VI: Experimental Patients receive immunization as in arm V. After injection, patients apply imiquimod at the site of once daily on days 1-5.	Drug: gp100 antigen Given subcutaneously Drug: imiquimod Applied at the site of injection Drug: incomplete Freund's adjuvant Given subcutaneously

Detailed Description:

OBJECTIVES:

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.

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.

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

Eligibility

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

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

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/mm^3
Platelet count ≥ 90,000/mm^3
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304057

Locations

United States, Maryland
NCI - Surgery Branch	Recruiting
Bethesda, Maryland, United States, 20892-1201
Contact: Steven A. Rosenberg, MD, PhD 866-820-4505 sar@nih.gov
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Steven A. Rosenberg, MD, PhD

NCI - Surgery Branch

More Information

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

Web site for additional information This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000465410, NCI-06-C-0069, NCI-7676, NCI-P6703
Study First Received:	March 15, 2006
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00304057
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II melanoma
stage III melanoma
stage IV melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Interferons
Neuroepithelioma

Freund's Adjuvant
Imiquimod
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Interferon Inducers
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Adjuvants, Immunologic
Nevi and Melanomas
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009