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Pilot Study of IFN α2b for Melanoma Patients

3 agosto 2017 aggiornato da: Ahmad Tarhini, University of Pittsburgh

Pilot Analysis of the Effects of IFN α2b Upon the Molecular Profile of Regional Lymph Nodes in Melanoma Patients With and Without Tumor-Involved Sentinel Lymph Nodes

The presence of malignant cells in lymph nodes is a critical parameter in the staging of melanoma cancer patients. Assessment of lymph nodes is currently done by histopathology alone. The long-term survival of melanoma cancer patients who have Stage IB disease (no known lymph node involvement with a tumor greater than 2 cm) is lower than patients who are Stage IA (no known lymph node involvement with a tumor less than 2 cm). Likewise, the survival rates of patients who are judged to be Stage II based on histologically positive level-one lymph nodes is often no better than that of higher stage patients who have level-two lymph node involvement. These observations suggest that micrometastases are often present in lymph nodes that are not detectable by histological assessment.

The collection of Sentinel Lymph Nodes (SLN) and non SLN material outlined in this proposal will permit both targeted and exploratory studies, without compromising the patient's diagnosis, on specimens that represent central engines of the immune response and whose function in the context of tumor progression is largely unknown.

With the advent of an array of new methodologies that utilize minimum material for both molecular and cellular assessments, acquiring up to 20% and in general the investigators anticipate the use of 5% on average of SLN and/or non SLN tissue for research purposes, may prove to be critical to understanding the impact of nodal tumor involvement on patient outcome and survival.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

50

Fase

  • Prima fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15232
        • UPMC Hillman Cancer Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Primary melanoma with the following Breslow thickness and stage

    • less than or equal to 2 mm
    • Patients with recent (within 12 wks) biopsy of primary melanoma that has not been widely resected will be eligible for study according to the above-specified criteria for tumor thickness and stage.
  • Age 18 years or older.
  • Patients must have documented hemoglobin level of 10g/dL or higher and normal organ function tests including BUN, Creatinine, and liver enzyme panel to include AST, ALT, and Bilirubin. This can be drawn on the day of consent, or be documented from a previous visit within the past 30 days
  • Negative serum pregnancy test
  • Subjects must have provided written, informed consent prior to any study procedures: collection of blood and LN tissue specimens for this protocol.

Exclusion Criteria:

  • Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, severe cardiac arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, inflammatory bowel disorders, severe renal disease.
  • Any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the Principal Investigator or Co-Investigators, could prevent adequate informed consent or compromise participation in the clinical trial.
  • Active infection or antibiotics within one-week prior to study.
  • Systemic steroid or other immunosuppressive therapy administered for more than 10 days within 4 weeks of enrollment.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 1
REGIONAL PEG IFN MAINTENANCE: Regional PEG IFN-a2b given subcutaneously at "MAINTENANCE" dose level. (This arm has completed enrollment; non-evaluable subjects as defined in section 9.5 may be replaced at any point during study.
Droga: IFNα2b
IV injection at 20 million IU/m2. IFNα2b IV injection will be performed every day between day -14 and day -9 (5 infusions) and also every day between day -7 and day -2 (5 infusions) for a total of 10 infusions.
Droga: IFNα2b
SC injections peri-lesionally (PL) in the vicinity of the primary, at 10 million IU/m2. IFNα2b Injection will be performed every other day between day -14 and day -9 (3 injections) and also every other day between day -7 and day -2 (3 injections) for a total of 6 injections.
Sperimentale: 2
No intervention / no injection control.
Droga: IFNα2b
IV injection at 20 million IU/m2. IFNα2b IV injection will be performed every day between day -14 and day -9 (5 infusions) and also every day between day -7 and day -2 (5 infusions) for a total of 10 infusions.
Droga: IFNα2b
SC injections peri-lesionally (PL) in the vicinity of the primary, at 10 million IU/m2. IFNα2b Injection will be performed every other day between day -14 and day -9 (3 injections) and also every other day between day -7 and day -2 (3 injections) for a total of 6 injections.
Sperimentale: 3
PEG IFN INDUCTION: System PEG IFN-a2b given subcutaneously at "INDUCTION" dose level
Droga: PEG- IFNα2b
SC injection at 6mcg/kg will be performed systemically (at site that is not regional): first injection at day -14, second injection at day -7, for a total of 2 injections.
Droga: PEG- IFNα2b
SC injections peri-lesionally (PL) in the vicinity of the primary at 3ug/kg: first injection at day -14, second injection at day -7, for a total of 2 injections.
Sperimentale: 4
REGIONAL HDI MAINTENANCE: Regional HDI given subcutaneously at "MAINTENANCE" dose level per standard HDI regimen
Droga: PEG- IFNα2b
SC injection at 6mcg/kg will be performed systemically (at site that is not regional): first injection at day -14, second injection at day -7, for a total of 2 injections.
Droga: PEG- IFNα2b
SC injections peri-lesionally (PL) in the vicinity of the primary at 3ug/kg: first injection at day -14, second injection at day -7, for a total of 2 injections.
Nessun intervento: 5
HDI Induction: Systemic HDI given intravenously at "INDUCTION" dose level per the standard HDI regimen.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
To utilize gene-profiling analysis of regional lymph node tissue to molecularly characterize the effect of IFN α2b and PEG IFNα2b on the SLN. Endpoint: mRNA expression by gene array.
Lasso di tempo: 5
5

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Quantitate putative biomarkers differentially expressed in the SLN for each active treatment group and among all active treatment groups combined. Endpoint: mRNA expression by Taqman.
Lasso di tempo: 5
5
Molecularly characterize the effect of perilesional IFN α2b and PEG IFNα2b administered as close as possible to the primary tumor site on SLNs that are positive vs. negative for tumor micrometastases. Endpoint: mRNA expression by gene array.
Lasso di tempo: 5
5

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pittsburgh

Collaboratori

Schering-Plough

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2009

Completamento primario (Effettivo)

1 agosto 2017

Completamento dello studio (Effettivo)

1 agosto 2017

Date di iscrizione allo studio

Primo inviato

26 marzo 2009

Primo inviato che soddisfa i criteri di controllo qualità

27 marzo 2009

Primo Inserito (Stima)

30 marzo 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 agosto 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 agosto 2017

Ultimo verificato

1 agosto 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 08-067

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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