Biological Therapy in Treating Patients With Metastatic Melanoma
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen Specific T Cell Clones Targeting Cancer Testis Antigens for Patients With Metastatic Melanoma
RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Treating a person's white blood cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
Primary
- Determine the safety and toxicity of cellular adoptive immunotherapy comprising autologous CD8+ cytotoxic T-lymphocyte clones targeting cancer-testis antigens in patients with metastatic melanoma.
- Determine the duration of in vivo persistence of this therapy in these patients.
Secondary
- Evaluate the antitumor effects of this therapy in these patients.
OUTLINE: Patients undergo leukapheresis to obtain peripheral blood mononuclear cells and then CD8+ cytotoxic T-lymphocyte (CTL) clones are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones targeting cancer testis antigens IV over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-4. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a clinical response after completion of the fourth course are eligible to receive additional T-cell infusions.
Patients are followed for 9 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.
Studietype
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Washington
-
Seattle, Washington, Forente stater, 98109-1024
- Fred Hutchinson Cancer Research Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic melanoma
- Stage IV disease
- HLA-A1, -A2, and -A3 positive
- MAGE-1 or -3 positive by histology
- Bidimensionally measurable disease by palpation on clinical examination, x-ray, or CT scan
- No CNS metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- Karnofsky 80-100%
Life expectancy
- More than 6 months
Hematopoietic
- Not specified
Hepatic
- Bilirubin ≤ 1.6 mg/dL
- SGOT ≤ 3 times upper limit of normal
- PT ≤ 1.5 times control
Renal
- Creatinine ≤ 2.0 mg/dL
- Calcium ≤ 12 mg/dL
Cardiovascular
- No congestive heart failure
- No clinically significant hypotension
- No symptoms of coronary artery disease
- No cardiac arrhythmias on electrocardiogram requiring drug therapy
- Patients with prior cardiovascular disease or the presence of any of the above abnormalities undergo a cardiac evaluation, which may include a stress test and/or echocardiogram
Pulmonary
- No clinically significant pulmonary dysfunction by medical history or physical examination
- FEV_1 ≥ 60% of normal
- DLCO ≥ 55% (corrected for hemoglobin)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No retinitis or choroiditis
- No active infections or oral temperature greater than 38.2 degrees Celsius within the past 72 hours
- No systemic infection requiring chronic maintenance or suppressive therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other concurrent immunotherapy (e.g., other interleukins, interferons, melanoma vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy)
Chemotherapy
- At least 3 weeks since prior standard or experimental chemotherapy
- 1-2 courses of prior cytoreductive chemotherapy for bulky disease allowed
Endocrine therapy
- No concurrent systemic steroids (except for toxicity management)
Radiotherapy
- At least 3 weeks since prior radiotherapy
Surgery
- Not specified
Other
- At least 3 weeks since prior immunosuppressive therapy
- No concurrent pentoxifylline
- No other concurrent investigational agents
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Masking: Ingen (Open Label)
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
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
Andre studie-ID-numre
- 1588.00
- FHCRC-1588.00
- NCI-H02-0091
- CDR0000256451 (Registeridentifikator: PDQ)
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