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
N/A
N/A
Both
Melanoma (Skin)
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Jeffrey S. Weber, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
USC/Norris Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000069468
NCT ID:
NCT00042783
Start Date:
September 2002
Completion Date:
March 2006
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
| University of Washington School of Medicine | Seattle, Washington 98195 |
