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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


Phase 2
N/A
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

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, UCLALos Angeles, California  90095-1781
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
University of Washington School of MedicineSeattle, Washington  98195