Tipifarnib in Treating Patients With Metastatic Malignant Melanoma
PHASE II TRIAL OF R115777 IN PATIENTS WITH METASTATIC MALIGNANT MELANOMA
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis, 60606
- Cancer and Leukemia Group B
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Études corrélatives
Donné oralement
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Response rate (complete response [CR] and partial response [PR]}
Délai: 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)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Correlation between RhoC expression levels and response
Délai: 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
Délai: 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
Délai: 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
Délai: Up to 2 years
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Up to 2 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Thomas Gajewski, Cancer and Leukemia Group B
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NCI-2012-02958
- U10CA031946 (Subvention/contrat des NIH des États-Unis)
- CALGB-500104
- CDR0000299508
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