Vaccine Therapy in Treating Patients With Metastatic Cancer
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|ClinicalTrials.gov Identifier: NCT00021164|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific||Biological: aldesleukin Biological: incomplete Freund's adjuvant Biological: telomerase: 540-548 peptide vaccine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Immunization of HLA-A*0201 Patients With Metastatic Cancer Using a Peptide Epitope From the Telomerase Antigen|
|Study Start Date :||May 2001|
|Study Completion Date :||May 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021164
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Steven A. Rosenberg, MD, PhD||NCI - Surgery Branch|