Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bethesda, Maryland 20892


Purpose:

RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer.


Study summary:

OBJECTIVES: - Determine whether an immunologic response can be obtained in HLA*0201-expressing patients with metastatic cancer treated with telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51. - Determine which vaccine strategy (frequency, schedule, and dosing) is best for future studies in these patients. - Determine the toxicity of this treatment in these patients. - Determine whether prior immunization with telomerase: 540-548 peptide vaccine results in increased clinical response to interleukin-2 in patients with melanoma. 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 three treatment arms. - Arm I: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 of weeks 1-4 and 7-10. Patients also undergo leukapheresis over 3 hours at baseline and after each course of treatment. - Arm II: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on day 1 of weeks 1, 4, 7, and 10. Patients also undergo leukapheresis over 3 hours at baseline, after the vaccine on week 4, and after each course of treatment. - Arm III: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on days 1-4 of weeks 1, 4, 7, and 10. Patients undergo leukapheresis as in arm II. Treatment in all arms repeats every 13 weeks for 4-6 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 1 additional course of treatment after achieving CR. Eligible melanoma patients with progressive disease on vaccine alone on any of the 3 arms may receive interleukin-2 (IL-2) combined with vaccine as in arm II. Beginning the day after each immunization, IL-2 is administered IV over 15 minutes every 8 hours over 4 days on weeks 1, 4, 7, and 10 for a maximum of 12 doses. Patients continuing to experience disease progression on combined vaccine and IL-2 therapy go off study after 2 courses of combined therapy. Patients are followed at 3 weeks. PROJECTED ACCRUAL: A total of 90-162 patients (30-54 per treatment arm; 45-81 per stratum) will be accrued for this study within less than 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Presenting with evaluable metastatic cancer - Refractory to standard treatment OR - Post-radiation for malignant glioma - HLA-A*0201 expression PATIENT CHARACTERISTICS: Age: - 16 and over Performance status: - ECOG 0-2 Life expectancy: - More than 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 90,000/mm^3 Hepatic: - Bilirubin no greater than 1.6 mg/dL - AST/ALT less than 3 times normal - Hepatitis B surface antigen negative Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No cardiac ischemia by stress thallium or comparable test* - No prior myocardial infarction* - No cardiac arrhythmias* NOTE: *Patients receiving interleukin-2 (IL-2) only Pulmonary: - No obstructive or restrictive pulmonary disease (patients receiving IL-2 only) Immunologic: - HIV negative - No autoimmune disease or any other known immunodeficiency disease - No active primary or secondary immunodeficiency Other: - No other active major medical illness* - No active systemic infection - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception NOTE: *Patients receiving IL-2 only PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior telomerase: 540-548 peptide immunization Chemotherapy: - Recovered from prior chemotherapy Endocrine therapy: - No requirement for systemic steroid therapy Radiotherapy: - See Disease Characteristics - Recovered from prior radiotherapy Surgery: - Not specified Other: - At least 3 weeks since prior systemic therapy for cancer


NCT ID:

NCT00021164


Primary Contact:

Study Chair
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.