Clinical trial NCT00020267: Vaccine Therapy in Treating Patients With Metastatic Cancer
Official title: Phase I Randomized Study of MAGE-12 Peptide Vaccine in Patients With Refractory Metastatic Cancer Expressing MAGE-12 Antigen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Adult Soft Tissue Sarcoma
Colorectal Cancer
Bone Cancer
Ovarian Sarcoma
Melanoma
Colon Cancer
Rectal Cancer
Breast Cancer
Eye Cancer
Uterine Sarcoma
Keywords: Ewing's family of tumors
adult soft tissue sarcoma
adult solid tumor
body system/site cancer
bone cancer
breast cancer
cancer
childhood cancer
childhood solid tumor
ciliary body and choroid melanoma, medium/large size
colon cancer
colorectal cancer
extraocular extension melanoma
eye cancer
female reproductive cancer
gastrointestinal cancer
genetic condition
intraocular melanoma
lung cancer
male breast cancer
melanoma
metastatic osteosarcoma
metastatic tumors of the Ewing's family
muscle cancer
musculoskeletal cancer
non-small cell lung cancer
osteosarcoma
osteosarcoma/malignant fibrous histiocytoma of bone
ovarian sarcoma
rectal cancer
recurrent adult soft tissue sarcoma
recurrent breast cancer
recurrent colon cancer
recurrent intraocular melanoma
recurrent melanoma
recurrent non-small cell lung cancer
recurrent osteosarcoma
recurrent rectal cancer
recurrent tumors of the Ewing's family
recurrent uterine sarcoma
skin tumor
solid tumor
stage IIIB, IV, recurrent, and metastatic breast cancer
stage IV adult soft tissue sarcoma
stage IV breast cancer
stage IV colon cancer
stage IV melanoma
stage IV non-small cell lung cancer
stage IV rectal cancer
stage IV uterine sarcoma
stage IVA adult soft tissue sarcoma
stage IVB adult soft tissue sarcoma
stage, Ewing's family of tumors
stage, adult soft tissue sarcoma
stage, breast cancer
stage, colon cancer
stage, intraocular melanoma
stage, melanoma
stage, non-small cell lung cancer
stage, osteosarcoma
stage, rectal cancer
stage, uterine sarcoma
thorax/respiratory cancer
uterine sarcoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-03-06
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Primary purpose: TREATMENT

Brief summary: RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer that has not responded to previous therapy.

Detailed description: OBJECTIVES: I. Determine the toxicity profile of MAGE-12 peptide vaccine in patients with refractory metastatic cancer that expresses MAGE-12 antigen.

II. Determine whether an immunologic response, as measured by an in vitro sensitization assay, can be obtained after administration of this regimen in these patients.

III. Determine a frequency of administration for this regimen based on immunologic response in these patients.

IV. Determine other immunologic parameters in these patients treated with this regimen.

V. Determine the clinical response rate in these patients treated with this regimen.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to disease (metastatic cutaneous melanoma vs other tumor types). Patients are randomized to one of two treatment arms.

Arm I: Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant subcutaneously (SC) weekly for 4 doses.

Arm II: Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant SC once every 3 weeks for 4 doses.

Patients with progressive disease may receive interleukin-2 IV over 15 minutes every 8 hours, beginning on the day after each immunization and continuing for up to 4 days. Patients achieving stable disease or a mixed, partial, or complete response continue on vaccine therapy alone for up to 24 total doses.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL:

A total of 26-56 patients (13-28 per treatment arm) will be accrued for this study within 1 year.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically documented metastatic cancer of one of the following types: Cutaneous melanoma Ocular melanoma Colorectal carcinoma Non-small cell lung cancer Breast carcinoma Sarcoma HLA-Cw\*0702 positive MAGE-12 expression by RT-PCR amplified tissue analysis Failed prior standard therapy Measurable or evaluable disease No renal carcinoma Hormone receptor status: Not specified --Prior/Concurrent Therapy-- Biologic therapy: At least 3 weeks since prior biologic therapy for cancer No other concurrent biologic therapy for cancer Chemotherapy: At least 3 weeks since prior chemotherapy for cancer and recovered No concurrent chemotherapy for cancer Endocrine therapy: At least 3 weeks since prior hormonal therapy for cancer No concurrent hormonal therapy for cancer No concurrent steroids Radiotherapy: At least 3 weeks since prior radiotherapy for cancer and recovered No concurrent radiotherapy for cancer Surgery: Prior surgery for cancer allowed --Patient Characteristics-- Age: 16 and over Sex: Male or female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 Hepatic: Bilirubin no greater than 1.6 mg/dL AST/ALT less than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No cardiac ischemia, myocardial infarction, or cardiac arrhythmias (if receiving interleukin-2 (IL-2) therapy) Pulmonary: No obstructive or restrictive pulmonary disease (if receiving IL-2 therapy) Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No active systemic infections No autoimmune disease, known immunodeficiency disease, or active primary or secondary immunodeficiency Hepatitis B surface antigen negative HIV negative No other active major medical illnesses (if receiving IL-2 therapy)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Surgery Branch
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Francesco M. Marincola
role: STUDY_CHAIR
References: