Vaccine Therapy in Treating Patients With Stage IV Melanoma - Full Text View

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00042783

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.

Condition	Intervention	Phase
Melanoma (Skin)	Drug: D1/3-MAGE-3-His fusion protein Drug: SB-AS02B adjuvant	Phase II

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

September 2002

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042783

Locations

United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Mississippi
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States, 39531-2410
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98195-6527

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Jeffrey S. Weber, MD, PhD

Norris Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000069468, SWOG-S0116
Study First Received:	August 5, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00042783
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 13, 2009