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Evaluate Safety/Tolerability Intra-Arterial Temozolomide in Patients w/Extremity Melanoma by Isolated Limb Infusion

6 marzo 2015 aggiornato da: Douglas Tyler

A Multi-Center Phase I Dose Escalation Trial to Evaluate Safety and Tolerability of Intra-Arterial Temozolomide for Patients With Advanced Extremity Melanoma Using Normothermic Isolated Limb Infusion

The purpose of this study is to determine the safety profile of intra-arterial temozolomide administration during Isolated Limb Infusion (ILI) by defining the dose limiting toxicities associated with this treatment. This study also aims to determine the maximum tolerated dose of intra-arterial administration of temozolomide during ILI that will be used in a phase II trial.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

  1. The primary objective of this study is to determine the safety profile of intra-arterial temozolomide administration during Isolated Limb Infusion (ILI) by defining the dose limiting toxicities associated with this treatment and to determine the maximum tolerated dose of intra-arterial administration of temozolomide during ILI that will be used in a phase II efficacy trial.
  2. Population will include patients who have undergone a previous Melphalan based regional therapy for which they did not respond optimally and present with persistent, progressive, or recurrent disease. Study activities include tumor tissue sampling, blood sampling, and subjects will undergo an Isolated Limb Infusion.
  3. To define both response in-field (area of the limb below the tourniquet) and out-of-field (any area outside the tourniquet) in patients treated with temozolomide based ILI. Response in this trial will be defined by the RECIST criteria (CR, PR, SD, PD at 12 weeks post ILI). A CR rate of 20% would be considered as preliminary evidence of a promising approach in this group of patients that have had a previous melphalan regional treatment. ILI with melphalan has a complete response rate of approximately 35% in naïve patients and 20% in patients who have previously received melphalan based regional therapy.

To assess if the proposed treatment has any effect on quality of life as measured by the Functional Assessment of Cancer Therapy - Melanoma.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

29

Fase

  • 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

    • Florida
      • Tampa, Florida, Stati Uniti, 33612
        • Moffitt Cancer Center
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke University Medical Center
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • MD Anderson 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:

  1. Patient must have undergone a previous Melphalan based regional therapy for which they did not respond optimally and present with persistent, progressive, or recurrent disease.
  2. Patient must be 18 years of age or older.
  3. Patient must have an ECOG status of 0-1.
  4. Patient must have histologically proven primary or recurrent extremity melanoma, stage IIIB, IIIC, or IV
  5. Patients with Stage IIIC disease must either have had regional lymph nodes previously removed or will have them removed at the time of regional treatment.
  6. Patients with Stage IV disease must have had all distant disease resected at least 30 days prior to regional treatment.
  7. Disease to be treated by ILI must be distal to the planned site of tourniquet placement
  8. Patient's disease must be bi-dimensionally measurable by caliper or radiological method as defined in the RECIST criteria.
  9. Patient must have adequate bone marrow, liver and renal function
  10. Patient must have a palpable femoral/radial pulse in the affected extremity.
  11. Recovery from relevant toxicity prior to first study drug administration.
  12. Patients must have a life expectancy of > 6 months.
  13. Ability to read and understand English and the ability to complete paper +/- electronic survey assessments.

Exclusion Criteria:

  1. Cardiac disease: Congestive heart failure > class II NYHA.
  2. Known brain metastasis.
  3. Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
  4. Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
  5. Active clinically serious infection > CTCAE Grade 2.
  6. Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  7. Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of administration of TMZ
  8. Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of administration of TMZ.
  9. Serious non-healing wound, ulcer, or bone fracture.
  10. Major surgery or significant traumatic injury within 30 days of ILI.
  11. Evidence or history of bleeding diathesis or coagulopathy.
  12. Antineoplastic therapy, radiotherapy, or any other investigational drug within 30 days prior to first study drug administration.
  13. Patients with symptoms or signs of vascular insufficiency. Specifically, patients with any history of blood clots or lifestyle altering ischemic peripheral vascular disease will be excluded.
  14. History of allergic reactions and/or hypersensitivity to TMZ.
  15. Psychiatric conditions or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance.
  16. Pregnant or nursing women are not eligible for this study. Patients of reproductive potential must agree to use an effective method of birth control when undergoing treatments with known or possible mutagenic or teratogenic effects. All female participants of child-bearing potential must have a negative serum pregnancy test within two weeks of patient registration. Please note: use of contraception, including surgical procedures such as vasectomy or tubal ligation DO NOT eliminate the need for administering pregnancy testing.
  17. Current treatment, or treatment in the previous 24 months, for another non-melanoma malignancy.
  18. Unable to return at the regular required intervals for reassessment, or study drug administration.
  19. Patients with known heparin induced thrombocytopenia.

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: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety Profile of intra-arterial temozolomide and maximum tolerated dose of temozolomide
Lasso di tempo: 12 Weeks

To determine the safety profile of intra-arterial temozolomide administration during Isolated Limb Infusion (ILI) by defining the dose limiting (DLT) and non dose limiting toxicities associated with this treatment.

To determine the maximum tolerated dose (MTD) for intra-arterial administration of temozolomide during ILI that will be used in a phase II efficacy trial.

12 Weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To define tumor response in field in patients treated with temozolomide
Lasso di tempo: Until disease progression or death
To define both response in-field (area of the limb below the tourniquet) and out-of-field (any area outside the tourniquet) in patients treated with temozolomide based ILI at the MTD dose. Response in this trial will be defined by the RECIST criteria (CR, PR, SD, PD at 12 weeks post ILI). A CR rate of 20% would be considered as preliminary evidence of a promising approach in this group of patients that have had a previous melphalan regional treatment. To assess if the proposed treatment has any effect on quality of life as measured by the Functional Assessment of Cancer Therapy - Melanoma.
Until disease progression or death

Collaboratori e investigatori

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

Sponsor

Collaboratori

Investigatori

  • Investigatore principale: Douglas S Tyler, MD, Duke University

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 luglio 2010

Completamento primario (Effettivo)

1 agosto 2013

Completamento dello studio (Effettivo)

1 giugno 2014

Date di iscrizione allo studio

Primo inviato

19 maggio 2010

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2010

Primo Inserito (Stima)

21 maggio 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

9 marzo 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 marzo 2015

Ultimo verificato

1 marzo 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • Pro00020406

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 .