Vaccine Therapy in Treating Patients With Metastatic Cancer

NCT00020267 | Completed Phase 1

• 3 other identifiers: CDR0000068173NCI-00-C-0182NCI-1034
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Interventions

interleukin-2 DRUG

MAGE-12 peptide vaccine DRUG

Montanide ISA-51 DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Surgery Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Sarcoma; Colorectal Neoplasms; Bone Neoplasms; Melanoma; Colonic Neoplasms; Rectal Neoplasms; Breast Neoplasms; Eye Neoplasms; Neuroectodermal Tumors, Primitive, Peripheral; Neoplasms; Uveal Melanoma; Gastrointestinal Neoplasms; Genetic Diseases, Inborn; Breast Neoplasms, Male; Osteosarcoma; Muscle Neoplasms; Carcinoma, Non-Small-Cell Lung; Histiocytoma, Malignant Fibrous; Skin Neoplasms; Recurrence

Interventions

Interleukin-2; montanide ISA 51

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Intestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Bone Diseases; Musculoskeletal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Diseases; Skin and Connective Tissue Diseases; Breast Diseases; Eye Diseases; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial; Uveal Neoplasms; Uveal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Soft Tissue Neoplasms; Muscular Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Histiocytoma; Neoplasms, Fibrous Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Francesco M. Marincola

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 6, 2007
• Study Start: July 1, 2000
• Last Updated: March 4, 2024

Record last verified: 2024-03

Locations

US (1)