- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01005537
Cyclophosphamide, Autologous Lymphocytes, and Aldesleukin in Treating Patients With Metastatic Melanoma
Single Patient Study to Evaluate Cellular Adoptive Immunotherapy Using Autologous Lymphocytes Following Cyclophosphamide Conditioning for a Single Patient With Metastatic Melanoma
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapy, such as cellular adoptive immunotherapy using autologous lymphocytes, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Giving cyclophosphamide together with autologous lymphocytes and aldesleukin may be an effective treatment for metastatic melanoma.
PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide together with autologous lymphocytes and aldesleukin and to see how well it works in treating patients with metastatic melanoma.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
Primary
- Assess the safety and toxicity of cellular adoptive immunotherapy with autologous tumor-infiltrating lymphocytes (TIL) following cyclophosphamide conditioning and post-infusion aldesleukin (IL-2) in patients with metastatic melanoma.
- Assess the duration of in vivo persistence of adoptively transferred lymphocytes.
Secondary
- Evaluate the antitumor effect of adoptively transferred autologous TIL following cyclophosphamide conditioning and post-infusion IL-2 in these patients.
OUTLINE: Patients receive cyclophosphamide IV on days -3 and -2 and autologous tumor-infiltrating lymphocytes (TIL) IV on day 0. Beginning 6 hours after TIL infusion, patients receive high-dose aldesleukin (IL-2) IV three times daily on days 0-5 (for up to 14 doses) OR low-dose IL-2 subcutaneously twice daily on days 0-14 (for up to 28 doses). Patients may then receive two additional courses of TILs and low-dose IL-2 (with or without cyclophosphamide), if indicated.
After completion of study treatment, patients are followed up periodically.
Tipo di studio
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria
- Histopathological documentation of melanoma concurrent with the diagnosis of metastatic disease.
- 18 to 75 years of age and able to tolerate high-dose cyclophosphamide
- Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, CT scan).
- For patients receiving HD-IL-2, normal cardiac stress test within 182 days prior to enrollment is required of all patients over 50 years old or those with an abnormal ECG, any history of cardiac disease, a family history of cardiac disease, hypercholesterolemia or hypertension.
For leukapheresis, patients must meet the following criteria (any exceptions to this will require prior approval by the Apheresis director and Principal Investigator):
- Pulse: >45 or < 120
- Weight: >45 kg
- Temperature: <38C (<100.4 F)
- WBC: >3,000
- HCT: >30%
- Platelets: >100,000
- ADDITIONAL INCLUSION CRITERIA FOR T CELL INFUSION
Exclusion Criteria
Significant cardiovascular abnormalities as defined by any one of the following:
- congestive heart failure,
- clinically significant hypotension,
- symptoms of coronary artery disease,
- presence of cardiac arrhythmias on EKG requiring drug therapy
- ejection fraction < 50 % (echocardiogram or MUGA)
- Patients with active infections or oral temperature > 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy.
Piano di studio
Come è strutturato lo studio?
Collaboratori e investigatori
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Collaboratori
Investigatori
- Investigatore principale: Cassian Yee, MD, Fred Hutchinson Cancer Center
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Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Tumori neuroectodermici
- Neoplasie, cellule germinali ed embrionali
- Neoplasie, tessuto nervoso
- Tumori neuroendocrini
- Nevi e melanomi
- Melanoma
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti antivirali
- Agenti anti-HIV
- Agenti antiretrovirali
- Agenti antireumatici
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti Antineoplastici, Alchilanti
- Agenti Alchilanti
- Agonisti mieloablativi
- Aldesleukin
- Ciclofosfamide
Altri numeri di identificazione dello studio
- 2355.00
- P30CA015704 (Sovvenzione/contratto NIH degli Stati Uniti)
- FHCRC-2355.00
- IR-6984
- CDR0000648071 (Identificatore di registro: PDQ)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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