Vaccine Therapy in Treating Patients With Stage IV Melanoma

Melanoma (Skin) Clinical Trial

Official title:

A Phase II Trial Of A D1/3-MAGE3-HIS Fusion Protein (NSC-719274) With Adjuvant SBAS02B (NSC-719275) For Patients With Stage IV, M1a or M1b Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00042783
• Other study ID #: CDR0000069468
• Secondary ID: SWOG-S0116
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2002
• Last updated: June 21, 2013
• Start date: September 2002
• Est. completion date: March 2006

Study information

• Verified date: April 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. Vaccine therapy may be effective in treating stage IV melanoma.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.

Description:

OBJECTIVES:

• Determine the feasibility of treating patients with stage IV melanoma with D1/3-MAGE-3-His fusion protein with SB-AS02B adjuvant.

• Determine the clinically confirmed response rates (partial and complete responses) of patients treated with this regimen.

• Determine the 6-month progression-free survival rate of patients treated with this regimen.

• Determine the qualitative and quantitative toxic effects of this regimen in these patients.

• Determine immune responses in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive D1/3-MAGE-3-His fusion protein emulsified in SB-AS02B adjuvant intramuscularly once every 3 weeks for a total of 12 weeks (4 injections). In the absence of disease progression or unacceptable toxicity, patients receive a second 12-week course beginning at week 16.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IV melanoma that is considered incurable by surgery, radiotherapy, or limb perfusion

• M1a or M1b disease

• Measurable disease outside prior field of limb perfusion

• Metastatic mucosal melanoma allowed

• MAGE-3 positive by reverse transcription polymerase chain reaction

• No uveal or choroidal primary melanoma

• No prior or concurrent brain metastases by CT scan or MRI of the brain

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Hepatitis B surface antigen negative

• Hepatitis C negative

• No liver cirrhosis

• No unstable liver disease

• No coagulation disorders

Renal

• Not specified

Cardiovascular

• No major cardiovascular illness

• No myocardial infarction within the past 6 months

Pulmonary

• No major pulmonary illness

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• HIV negative

• No AIDS or HIV-1-associated complex

• No chronic alcohol abuse or drug addiction

• No systemic infections

• No prior active autoimmune disease

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently disease-free

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 4 weeks since prior adjuvant biologic therapy

• No prior biologic therapy for stage IV melanoma

• No prior MAGE-3 peptide or protein vaccine preparation

Chemotherapy

• At least 4 weeks since prior adjuvant chemotherapy

• No prior chemotherapy for stage IV melanoma

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior adjuvant radiotherapy

Surgery

• At least 4 weeks since prior surgery

Other

• See Disease Characteristics

• At least 3 weeks since prior limb perfusion and recovered

• At least 4 weeks since other prior adjuvant therapy

• No other prior therapy for stage IV melanoma

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• D1/3-MAGE-3-His fusion protein

• SB-AS02B adjuvant

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center - Biloxi	Biloxi	Mississippi
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	University of Washington School of Medicine	Seattle	Washington
United States	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,