Evaluate Safety/Tolerability Intra-Arterial Temozolomide in Patients w/Extremity Melanoma by Isolated Limb Infusion
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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
- 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.
- 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.
- 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
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 1
Contatti e Sedi
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
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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.
- Patient must be 18 years of age or older.
- Patient must have an ECOG status of 0-1.
- Patient must have histologically proven primary or recurrent extremity melanoma, stage IIIB, IIIC, or IV
- 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.
- Patients with Stage IV disease must have had all distant disease resected at least 30 days prior to regional treatment.
- Disease to be treated by ILI must be distal to the planned site of tourniquet placement
- Patient's disease must be bi-dimensionally measurable by caliper or radiological method as defined in the RECIST criteria.
- Patient must have adequate bone marrow, liver and renal function
- Patient must have a palpable femoral/radial pulse in the affected extremity.
- Recovery from relevant toxicity prior to first study drug administration.
- Patients must have a life expectancy of > 6 months.
- Ability to read and understand English and the ability to complete paper +/- electronic survey assessments.
Exclusion Criteria:
- Cardiac disease: Congestive heart failure > class II NYHA.
- Known brain metastasis.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- Active clinically serious infection > CTCAE Grade 2.
- Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of administration of TMZ
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of administration of TMZ.
- Serious non-healing wound, ulcer, or bone fracture.
- Major surgery or significant traumatic injury within 30 days of ILI.
- Evidence or history of bleeding diathesis or coagulopathy.
- Antineoplastic therapy, radiotherapy, or any other investigational drug within 30 days prior to first study drug administration.
- 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.
- History of allergic reactions and/or hypersensitivity to TMZ.
- Psychiatric conditions or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance.
- 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.
- Current treatment, or treatment in the previous 24 months, for another non-melanoma malignancy.
- Unable to return at the regular required intervals for reassessment, or study drug administration.
- Patients with known heparin induced thrombocytopenia.
Piano di studio
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
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
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
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Douglas S Tyler, MD, Duke University
Studiare le date dei record
Studia le date principali
Inizio studio
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
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
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Agenti Antineoplastici, Alchilanti
- Agenti Alchilanti
- Temozolomide
Altri numeri di identificazione dello studio
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 .