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Vaccine Therapy in Treating Patients With Metastatic Cancer

This study has been completed.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020267
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Adult Soft Tissue Sarcoma
Colorectal Cancer
Bone Cancer
Ovarian Sarcoma
Melanoma
Colon Cancer
Rectal Cancer
Breast Cancer
Eye Cancer
Uterine Sarcoma
Drug: interleukin-2
Drug: MAGE-12 peptide vaccine
Drug: Montanide ISA-51
Phase I

Genetics Home Reference related topics:   breast cancer    retinoblastoma   

MedlinePlus related topics:   Bone Cancer    Breast Cancer    Cancer    Colorectal Cancer    Eye Cancer    Lung Cancer    Melanoma    Soft Tissue Sarcoma   

Drug Information available for:   Interleukin-2    Montanide ISA 51   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Randomized Study of MAGE-12 Peptide Vaccine in Patients With Refractory Metastatic Cancer Expressing MAGE-12 Antigen

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

Study Start Date:   July 2000

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
Ages Eligible for Study:   16 Years and older

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)

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020267

Locations
United States, Maryland
Surgery Branch    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

Investigators
Study Chair:     Francesco M. Marincola     National Cancer Institute (NCI)    
  More Information


Study ID Numbers:   CDR0000068173, NCI-00-C-0182, NCI-1034
First Received:   March 2, 2007
Last Updated:   March 2, 2007
ClinicalTrials.gov Identifier:   NCT00020267
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Bone Neoplasms
Rectal Neoplasms
Histiocytoma, Benign Fibrous
Malignant mesenchymal tumor
Colonic Diseases
Rectal Diseases
Osteogenic sarcoma
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Lung Neoplasms
Intraocular melanoma
Neoplasm Metastasis
Neuroepithelioma
Rectal cancer
Breast Diseases
Non-small cell lung cancer
Digestive System Neoplasms
Eye Neoplasms
Breast Neoplasms
Melanoma of the choroid
Neuroectodermal Tumors
Histiocytoma
Breast Neoplasms, Male
Lung Diseases
Sarcoma
Gastrointestinal Neoplasms
Uterine sarcoma
Nevus
Colonic Neoplasms

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Nevi and Melanomas
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2008




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