Los Angeles, California 90095

  • Melanoma (Skin)

Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

CDR0000069468


NCT ID:

NCT00042783


Secondary ID:

SWOG-S0116


Study Acronym:


Brief Title:

Vaccine Therapy in Treating Patients With Stage IV Melanoma


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Jeffrey S. Weber, MD, PhD
Study Chair
USC/Norris Comprehensive Cancer Center

Study Dates

Start Date:September 2002
Completion Date:March 2006
Completion Type:Actual
Verification Date:April 2004
Last Changed Date:June 21, 2013
First Received Date:August 5, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:D1/3-MAGE-3-His fusion protein
Intervention Type:Biological
Name:SB-AS02B adjuvant

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southwest Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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