- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00019487
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Treatment of Patients With Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response and kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Determine whether reinfused activated cells alone or in conjunction with high or subcutaneous dose interleukin-2 may result in clinical tumor regression in patients with metastatic melanoma who had previously failed therapy on protocols involving immunization against the gp100 molecule.
- Determine the survival of infused cells with antitumor activity in these patients.
OUTLINE: This is a salvage regimen.
Patients undergo leukopheresis to obtain peripheral blood mononuclear cells or tumor biopsy to obtain tumor infiltrating lymphocytes (TIL). Cells are incubated in the presence of gp209-2M peptide and then harvested and cloned. Patients receive 30-minute IV infusions of these in vitro sensitized cells. Treatment repeats every 2 weeks for 2 courses. An additional cohort of 8 patients receives gp209-2M peptide in Montanide ISA-51 subcutaneously in 2 different sites followed 2 days later by the adoptive transfer of cloned lymphocytes. At 4 to 6 weeks after the treatment courses, patients with stable or regressing disease may be retreated.
Patients with disease progression after 2 courses may receive 2 additional courses of cell infusion followed by interleukin-2 (IL-2) on one of two schedules. One cohort of patients receives IL-2 by intravenous bolus over 15 minutes every 8 hours beginning on the day after cell infusion and continuing for up to 5 days of each treatment course. Another cohort receives IL-2 by daily subcutaneous injections on days 1-12 of each course of therapy. If after 12-16 patients have been treated with cloned cells alone initially and responses are inadequate, subsequent patients entered into this study are randomized to receive the cell infusion followed by IL-2 on one of the two described schedules.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: A total of 91 patients will be accrued for this study over 2 years.
Studietype
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Maryland
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Bethesda, Maryland, Forente stater, 20892
- 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:
- Histologically proven metastatic melanoma that has failed therapy on protocols involving immunization against the gp100 molecule
- Measurable or evaluable metastatic disease
- Must be HLA-A201 positive by standard HLA typing
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Greater than 3 months
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 8.0 g/dL
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- ALT/AST less than 4 times upper limit of normal
Renal:
- Creatinine no greater than 1.6 mg/dL
Cardiovascular:
For patients randomized to receive interleukin-2:
- No major medical illnesses of the cardiovascular system
Pulmonary:
For patients randomized to receive interleukin-2:
- No major medical illnesses of the pulmonary system
Other:
- HIV negative
- Hepatitis B antigen negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
For patients randomized to receive interleukin-2:
- No active systemic infection
- No other major medical illnesses of immune system
- No coagulation disorders
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior biologic therapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- No concurrent steroid therapy
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- No concurrent active treatment of brain metastases
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
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
- Adjuvanser, immunologiske
- Aldesleukin
- Freunds adjuvans
Andre studie-ID-numre
- CDR0000066287
- NCI-98-C-0095
- NCI-T98-0012
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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