Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma That Has Not Responded to Previous Treatment

Melanoma (Skin) Clinical Trial

Official title:

Immunization of HLA-0201 Positive Patients With Metastatic Melanoma Using a Peptide From Tyrosinase-related Protein 2 (TRP-2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022438
• Other study ID #: CDR0000068818
• Secondary ID: NCI-01-C-0193NCI
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2001
• Last updated: June 17, 2013
• Start date: June 2001
• Est. completion date: August 2004

Study information

• Verified date: July 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus interleukin-2 to that of vaccine therapy alone in treating patients who have metastatic melanoma that has not responded to previous treatment.

Description:

OBJECTIVES:

• Determine the clinical responses in patients with HLA-A0201-positive refractory metastatic melanoma treated with tyrosinase-related protein-2:180-188 peptide vaccine alone.

• Determine the clinical response rate of patients who have an immediate need to receive interleukin-2 (IL-2) in addition to this vaccine.

• Compare the immunologic response, in terms of changes in T-cell precursors before and after treatment, in patients treated with this vaccine with or without IL-2.

• Compare the toxicity profile of these regimens in these patients.

OUTLINE: This is a randomized, open-label study.

Patients who need immediate interleukin-2 (IL-2) receive tyrosinase-related protein-2 (TRP-2):180-188 peptide vaccine emulsified with Montanide ISA-51 on day 1 and high-dose IL-2 IV over 15 minutes once every 8 hours on days 2-5. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients who do not need immediate IL-2 are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive TRP-2:180-188 peptide vaccine emulsified with Montanide ISA-51 subcutaneously (SC) on day 1. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive TRP-2:180-188 peptide vaccine emulsified with Montanide ISA-51 SC once weekly on weeks 1-4. Treatment repeats every 7 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients who have a complete response (CR) receive 1 additional course after achieving CR. Patients who have progressive disease while receiving vaccine alone may cross over to receive peptide vaccine with IL-2 for at least 2 courses.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A maximum of 83 patients (19-33 who need immediate interleukin-2 (IL-2); 15-25 per treatment arm who do not need immediate IL-2) will be accrued for this study within 1 year.

Other known NCT identifiers

• NCT00017849

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic melanoma

• Refractory to standard therapy

• No resectable locoregional disease

• HLA-A0201 positive

• Measurable disease

• Previously resected brain metastases, brain metastases stable after prior radiosurgery, or brain metastases less than 1 cm and without edema allowed

PATIENT CHARACTERISTICS:

Age:

• 16 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm^3

• Platelet count at least 90,000/mm^3

• No coagulation disorders

Hepatic:

• Bilirubin no greater than 2.0 mg/dL (3.0 mg/dL for 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

Cardiovascular:

• No major medical illness of the cardiovascular system

• No cardiac ischemia*

• No myocardial infarction*

• No cardiac arrhythmias* NOTE: * For interleukin-2 (IL-2) administration

Pulmonary:

• No major medical illness of the respiratory system

• No obstructive or restrictive pulmonary disease (for IL-2 administration)

Immunologic:

• HIV negative

• No primary or secondary immunodeficiency

• No known immunodeficiency disease

• No autoimmune disease

• No active systemic infections

Other:

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic therapy for melanoma

• No prior immunization to tyrosinase-related protein-2 antigen

• No other concurrent biologic therapy for melanoma

Chemotherapy:

• At least 3 weeks since prior chemotherapy for melanoma and recovered

• No concurrent chemotherapy for melanoma

Endocrine therapy:

• At least 3 weeks since prior endocrine therapy for melanoma

• No concurrent systemic steroid therapy

• No concurrent endocrine therapy for melanoma

Radiotherapy:

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy for melanoma and recovered

• No concurrent radiotherapy for melanoma

Surgery:

• See Disease Characteristics

Other:

• No other concurrent therapy for melanoma

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• aldesleukin

• incomplete Freund's adjuvant

• recombinant tyrosinase-related protein-2

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,