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| Sponsor: | 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 |
| 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 |
| Study Start Date: | July 2000 |
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 |
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
More Information
| Study ID Numbers: | CDR0000068173, NCI-00-C-0182, NCI-1034 |
| Study First Received: | March 2, 2007 |
| Last Updated: | March 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00020267 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
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Thoracic Neoplasms Bone Neoplasms Antineoplastic Agents Rectal Neoplasms Gastrointestinal Diseases Physiological Effects of Drugs Neoplasms, Nerve Tissue Colonic Diseases Bone Diseases Rectal Diseases Melanoma Neoplasms, Connective and Soft Tissue Neoplastic Processes Pathologic Processes Neoplasms by Site |
Respiratory Tract Diseases Musculoskeletal Diseases Sensory System Agents Lung Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Neoplasm Metastasis Nevi and Melanomas Analgesics Breast Diseases Respiratory Tract Neoplasms Neoplasms by Histologic Type Digestive System Neoplasms Eye Neoplasms Skin Diseases |