Vaccine Therapy in Treating Patients With Metastatic Cancer
Immunization of HLA-A*0201 Patients With Metastatic Cancer Using a Peptide Epitope From the Telomerase Antigen
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Maryland
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Bethesda, Maryland, Forente stater, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer etter histologisk type
- Neoplasmer
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Neoplastiske prosesser
- Nevroendokrine svulster
- Nevi og melanomer
- Neoplasma Metastase
- Melanom
- Fysiologiske effekter av legemidler
- Anti-infeksjonsmidler
- Antivirale midler
- Anti-HIV-midler
- Antiretrovirale midler
- Antineoplastiske midler
- Immunologiske faktorer
- Adjuvanser, immunologiske
- Aldesleukin
- Freunds adjuvans
Andre studie-ID-numre
- CDR0000068756
- NCI-01-C-0176
- NCI-4970
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