- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00020267
Vaccine Therapy in Treating Patients With Metastatic Cancer
Phase I Randomized Study of MAGE-12 Peptide Vaccine in Patients With Refractory Metastatic Cancer Expressing MAGE-12 Antigen
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- Surgery Branch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Francesco M. Marincola, National Cancer Institute (NCI)
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV breast cancer
- recurrent breast cancer
- recurrent non-small cell lung cancer
- stage IV non-small cell lung cancer
- colorectal cancer
- breast cancer
- stage IV rectal cancer
- stage IV colon cancer
- recurrent colon cancer
- recurrent rectal cancer
- lung cancer
- cancer
- non-small cell lung cancer
- rectal cancer
- male breast cancer
- osteosarcoma
- colon cancer
- recurrent melanoma
- stage IV melanoma
- ciliary body and choroid melanoma, medium/large size
- extraocular extension melanoma
- recurrent intraocular melanoma
- adult solid tumor
- solid tumor
- melanoma
- eye cancer
- gastrointestinal cancer
- intraocular melanoma
- body system/site cancer
- bone cancer
- childhood cancer
- stage IV adult soft tissue sarcoma
- recurrent adult soft tissue sarcoma
- stage IV uterine sarcoma
- recurrent uterine sarcoma
- ovarian sarcoma
- metastatic osteosarcoma
- recurrent osteosarcoma
- genetic condition
- stage, colon cancer
- stage, non-small cell lung cancer
- stage, rectal cancer
- thorax/respiratory cancer
- skin tumor
- stage, melanoma
- uterine sarcoma
- adult soft tissue sarcoma
- Ewing's family of tumors
- childhood solid tumor
- muscle cancer
- musculoskeletal cancer
- osteosarcoma/malignant fibrous histiocytoma of bone
- recurrent tumors of the Ewing's family
- stage, Ewing's family of tumors
- stage, osteosarcoma
- stage IVA adult soft tissue sarcoma
- stage IVB adult soft tissue sarcoma
- stage, adult soft tissue sarcoma
- stage, intraocular melanoma
- stage IIIB, IV, recurrent, and metastatic breast cancer
- stage, breast cancer
- female reproductive cancer
- metastatic tumors of the Ewing's family
- stage, uterine sarcoma
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Eye Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Breast Diseases
- Musculoskeletal Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Bone Diseases
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Sarcoma
- Breast Neoplasms
- Lung Neoplasms
- Colorectal Neoplasms
- Bone Neoplasms
- Rectal Neoplasms
- Melanoma
- Osteosarcoma
- Colonic Neoplasms
- Eye Neoplasms
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interleukin-2
- Monatide (IMS 3015)
Other Study ID Numbers
- CDR0000068173
- NCI-00-C-0182
- NCI-1034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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