- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00054535
Vaccine Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma
Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2
RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have metastatic melanoma.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
OBJECTIVES:
- Determine the response rate (partial response or complete remission) in patients with metastatic melanoma treated with vaccinia-tyrosinase vaccine, fowlpox-tyrosinase vaccine, and high-dose interleukin-2.
- Determine the immunologic response, measured by the reactivity of CD4+ and CD8+ T cells and serum immunoglobulins against tyrosinase and melanoma cells, in patients treated with this regimen.
OUTLINE: Patients receive vaccinia-tyrosinase vaccine intramuscularly (IM) on day 1 followed by fowlpox-tyrosinase vaccine IM on days 15 and 29. Patients then receive high-dose interleukin-2 (IL-2) IV over 15 minutes every 8 hours beginning on day 30 for up to 12 doses and again beginning approximately 3 weeks after the initial dose. Patients with stable disease or a minor, mixed, or partial response may receive additional courses of fowlpox-tyrosinase vaccine (2 doses) and IL-2 as above in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 1 additional course beyond achieving CR.
Patients are followed annually for at least 5 years.
PROJECTED ACCRUAL: A total of 19-35 patients will be accrued for this study within 2 years.
Studietype
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Maryland
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Bethesda, Maryland, Forente stater, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Diagnosis of metastatic melanoma
- Measurable disease
- Disease progression while receiving prior standard treatment
- No ocular or mucosal primary site
- No uncontrolled brain metastases
PATIENT CHARACTERISTICS:
Age
- 16 and over
Performance status
- ECOG 0-1
Life expectancy
- More than 3 months
Hematopoietic
- WBC at least 3,000/mm^3
- Platelet count at least 90,000/mm^3
- No coagulation disorders
Hepatic
- Bilirubin no greater than 1.6 mg/dL (less than 3.0 mg/dL in patients with Gilbert's syndrome)
- AST/ALT less than 3 times normal
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal
- Creatinine no greater than 1.6 mg/dL
Cardiovascular
- No major cardiovascular illness
Pulmonary
- No major respiratory illness
Immunologic
- HIV negative
- No autoimmune disease
- No active systemic infections
- No primary or secondary immunodeficiency (e.g., hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome or acquired immunodeficiencies after bone marrow transplantation)
- No allergy to eggs
- No prior allergy or untoward reaction to smallpox vaccination (if previously vaccinated)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
No close contact with the following individuals for 2 weeks after vaccinia vaccination:
- Children under 5 years of age
- Pregnant women
- Individuals with prior or active eczema or other eczematoid skin disorders
- Individuals with other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
- Immunosuppressed individuals
- No active atopic dermatitis
- No prior or active eczema
No active cases of the following conditions:
- Extensive psoriasis
- Severe acneiform rash
- Impetigo
- Varicella zoster
- Burns
- Traumatic or pruritic skin conditions
- Open wounds
No unhealed surgical scars
- Healed surgical stomas (e.g., colostomy) allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior recombinant vaccinia or fowlpox vaccines for melanoma
No prior vaccination with full length tyrosinase protein, or a vector encoding the full length protein for melanoma
- Prior individual tyrosinase peptides are allowed
- No prior high-dose interleukin-2
Chemotherapy
- Not specified
Endocrine therapy
- No concurrent oral, IV, topical, or inhaled steroids
Radiotherapy
- Not specified
Surgery
- Recovered from prior surgery
Other
- Recovered from prior therapy for melanoma
- More than 3 weeks since prior systemic therapy for melanoma
- No other concurrent systemic therapy for melanoma
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Masking: Ingen (Open Label)
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Suzanne L. Topalian, MD, NCI - Surgery Branch
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
- Neoplasmer etter histologisk type
- Neoplasmer
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Nevroendokrine svulster
- Nevi og melanomer
- Melanom
- Fysiologiske effekter av legemidler
- Anti-infeksjonsmidler
- Antivirale midler
- Anti-HIV-midler
- Antiretrovirale midler
- Antineoplastiske midler
- Immunologiske faktorer
- Aldesleukin
- Vaksiner
Andre studie-ID-numre
- CDR0000270794
- NCI-03-C-0080
- NCI-6119
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