Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma

Melanoma (Skin) Clinical Trial

Official title:

A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00037037
• Other study ID #: CDR0000069357
• Secondary ID: CPMC-IRB-13824LU
• Status: Active, not recruiting
• Phase: Phase 1
• First received: May 13, 2002
• Last updated: December 17, 2013
• Start date: October 2001

Study information

• Verified date: May 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 made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma.

Description:

OBJECTIVES:

• Compare the safety of melanoma peptide vaccine with or without sargramostim (GM-CSF) in patients with high-risk or metastatic melanoma.

• Compare changes in peptide-specific cellular and humoral immunologic profiles in patients treated with these regimens.

• Compare tumor response in patients treated with these regimens.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive melanoma peptide vaccine comprising tyrosinase leader injected at 2 separate sites, Melan-A ELA injected at another site, NY-ESO-1a and NY-ESO-1b combined and injected at one site, and MAGE-10.A2 injected at another site, intradermally once weekly on weeks 1-6.

• Arm II: Patients receive vaccine as in arm I. Patients also receive sargramostim (GM-CSF) subcutaneously daily beginning 2 days before each vaccination and continuing for 5 days.

Treatment in both arms continues through week 6 in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study within 18 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed high-risk stage III or IV melanoma

• Stage III disease less than 6 months after surgical resection

• Completed prior interferon alfa therapy OR

• Progressive disease or major adverse events during prior interferon alfa therapy

• Stage III disease at least 6 months after surgical resection

• Declined, failed, or completed prior standard therapy

• Stage IV disease

• Declined, failed, or completed prior standard therapy

• HLA-A2 positive

• No CNS metastases unless treated and stable

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 80-100%

Life expectancy:

• At least 4 months

Hematopoietic:

• Neutrophil count at least 1,500/mm3

• Lymphocyte count at least 500/mm3

• Platelet count at least 100,000/mm3

• Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg)

• No bleeding disorder

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

• No hepatitis B or C positivity

Renal:

• Creatinine no greater than 1.8 mg/dL

Cardiovascular:

• No New York Heart Association class III or IV heart disease

Other:

• HIV negative

• No other serious illness

• No serious infection requiring antibiotics

• No history of immunodeficiency disease or autoimmune disease

• No psychiatric or addictive disorder that would preclude study

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

• No prior bone marrow or stem cell transplantation

• At least 4 weeks since prior immunotherapy or biologic therapy

• No other concurrent immunotherapy or biologic therapy

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

• No concurrent chemotherapy

Endocrine therapy:

• No concurrent systemic corticosteroids

• No concurrent steroids except topical or inhalational steroids

• Concurrent hormonal therapy allowed

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• See Disease Characteristics

• At least 4 weeks since prior surgery

Other:

• At least 4 weeks since prior investigational agents

• Concurrent noncytotoxic anticancer therapy allowed

• No concurrent immunosuppressive therapy

• No concurrent antihistamines

• No concurrent non-steroidal anti-inflammatory drugs except in low doses for prevention of an acute cardiovascular event or pain control

Study Design

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• MAGE-10.A2

• MART-1 antigen

• NY-ESO-1 peptide vaccine

• sargramostim

• tyrosinase peptide

Locations

Country	Name	City	State
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Herbert Irving Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,