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Vaccine Therapy in Treating Patients With Stage IV Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
D1/3-MAGE-3-His fusion protein
SB-AS02B adjuvant
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Cancer Center at University of Arizona Health Sciences Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Jonsson Comprehensive Cancer Center, UCLA
  • Barbara Ann Karmanos Cancer Institute
  • Veterans Affairs Medical Center - Biloxi
  • CCOP - Columbia River Oncology Program
  • University of Washington School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 5, 2002
Last Updated
June 21, 2013
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00042783
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
D1/3-MAGE-3-His fusion protein
Intervention Type
Biological
Intervention Name(s)
SB-AS02B adjuvant

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S. Weber, MD, PhD
Organizational Affiliation
University of Southern California
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Cancer Center at University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Veterans Affairs Medical Center - Biloxi
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531-2410
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6527
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy in Treating Patients With Stage IV Melanoma

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