Tipifarnib in Treating Patients With Metastatic Malignant Melanoma
PHASE II TRIAL OF R115777 IN PATIENTS WITH METASTATIC MALIGNANT MELANOMA
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. To estimate the clinical response rate in patients with metastatic malignant melanoma treated with R115777 (tipifarnib).
II. To evaluate the safety of R115777 in patients with metastatic melanoma.
SECONDARY OBJECTIVES:
I. To assess RhoC expression in tumor samples pre- and post- therapy with R115777.
II. To evaluate Ftase levels in peripheral blood and tumor samples pre- and post-therapy with R115777.
III. To assess the effect of R115777 treatment on T lymphocyte cytokine production, pre- and post- therapy with R115777.
IV. Estimate time to treatment failure (TTF). Time to treatment failure is defined as time to withdrawal for unacceptable toxicity or progressive disease.
OUTLINE Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for at least 2 courses and for a maximum of 2 years in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond CR.
Patients who discontinue therapy due to toxicity or complete response are followed every 3 months for 2 years after study entry. Patients who discontinue therapy due to disease progression are followed every 6 months for 2 years after study entry. Patients with stable or partially responding disease who complete treatment are followed at 2 years after study entry.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
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Illinois
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Chicago, Illinois, Stati Uniti, 60606
- Cancer and Leukemia Group B
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Histological or cytological diagnosis of cutaneous melanoma and clinical evidence of distant metastatic, non-resectable regional lymphatic, or extensive in transit recurrent disease
Patients must have at least 2 cutaneous lesions amenable to excisional biopsy for correlative studies; in addition, patients must have measurable disease; the disease remaining after the first excisional biopsy must be measurable; lesions that are considered intrinsically non-measurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Lesions that are situated in a previously irradiated area
- No history of brain metastases
- No allergies to azoles (e.g. ketoconazole) or allergies to compounds structurally similar to R115777
No more than 1 prior immunotherapy regimen for treatment of advanced melanoma; an additional immunologic therapy in the adjuvant setting (e.g. IFN-a) is acceptable; prior chemotherapy for any stage of melanoma is not allowed
- No radiotherapy or immunotherapy within four weeks prior to the initiation of therapy on this study
- CTC (ECOG) performance status 0-1
- Non-pregnant, non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control; women of child-bearing age will undergo pregnancy testing
- ANC >= 1500/uL
- Platelets >= 100,000/uL
- Bilirubin =< 1.5 mg/dL
- Creatinine =< 2.0 mg/dL
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)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Treatment (tipifarnib)
Patients receive oral tipifarnib twice daily on days 1-21.
Treatment repeats every 28 days for at least 2 courses and for a maximum of 2 years in the absence of disease progression or unacceptable toxicity.
Patients who achieve CR receive 2 additional courses beyond CR.
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Studi correlati
Dato oralmente
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Response rate (complete response [CR] and partial response [PR]}
Lasso di tempo: Up to 2 years
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Estimated confidence intervals will be adjusted for the number of stages.
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Up to 2 years
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Progression-free survival (PFS)
Lasso di tempo: From date of entry onto the trial until documented progression or death from any cause, assessed up to 2 years
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Estimated using the method of Kaplan and Meier.
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From date of entry onto the trial until documented progression or death from any cause, assessed up to 2 years
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Time to treatment failure (TTF)
Lasso di tempo: From trial entry until a patient ends protocol therapy due to unacceptable toxicity, progression or death from any cause, assessed up to 2 years
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Estimated using the method of Kaplan and Meier.
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From trial entry until a patient ends protocol therapy due to unacceptable toxicity, progression or death from any cause, assessed up to 2 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Correlation between RhoC expression levels and response
Lasso di tempo: From baseline to up to 2 years
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From baseline to up to 2 years
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Change in FTAse levels
Lasso di tempo: From baseline to up to 2 years
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From baseline to up to 2 years
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Change in the production of IL-2 and IFN-g by T cells
Lasso di tempo: From baseline to up to 2 years
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Descriptive statistics will be used to describe the mean and spread of production of IL-2 and IFN-g.
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From baseline to up to 2 years
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Adverse events as assessed by Common Toxicity Criteria (CTC) version 2.0
Lasso di tempo: Up to 2 years
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Up to 2 years
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Thomas Gajewski, Cancer and Leukemia Group B
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NCI-2012-02958
- U10CA031946 (Sovvenzione/contratto NIH degli Stati Uniti)
- CALGB-500104
- CDR0000299508
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