Vaccine Therapy in Treating Patients Wi… | Clinical Trial

Key information

Conditions

Lung Cancer Adult Soft Tissue Sarcoma Bone Cancer Bone Diseases Bone Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Breast Neoplasms, Male Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Cancer Colorectal Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Disease Attributes Eye Cancer Eye Diseases Eye Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Histiocytoma Histiocytoma, Malignant Fibrous Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Melanoma Muscle Neoplasms Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Neuroendocrine Tumors Nevi and Melanomas Osteosarcoma Ovarian Sarcoma Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Cancer Rectal Diseases Rectal Neoplasms Recurrence Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Soft Tissue Neoplasms Thoracic Neoplasms Uterine Sarcoma Uveal Diseases Uveal Melanoma Uveal Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Surgery Branch

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Interleukin-2

Drug

MAGE-12 peptide vaccine

Drug

Montanide ISA-51

Drug

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

Phase I Randomized Study of MAGE-12 Peptide Vaccine in Patients With Refractory Metastatic Cancer Expressing MAGE-12 Antigen

Important dates

Study start: 2000
First posted: Mar 6, 2007
Registry last updated: Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed