Tipifarnib in Treating Patients With Metastatic Malignant Melanoma
PHASE II TRIAL OF R115777 IN PATIENTS WITH METASTATIC MALIGNANT MELANOMA
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
Illinois
-
Chicago, Illinois, Vereinigte Staaten, 60606
- Cancer and Leukemia Group B
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
Korrelative Studien
Mündlich gegeben
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Response rate (complete response [CR] and partial response [PR]}
Zeitfenster: Up to 2 years
|
Estimated confidence intervals will be adjusted for the number of stages.
|
Up to 2 years
|
|
Progression-free survival (PFS)
Zeitfenster: From date of entry onto the trial until documented progression or death from any cause, assessed up to 2 years
|
Estimated using the method of Kaplan and Meier.
|
From date of entry onto the trial until documented progression or death from any cause, assessed up to 2 years
|
|
Time to treatment failure (TTF)
Zeitfenster: From trial entry until a patient ends protocol therapy due to unacceptable toxicity, progression or death from any cause, assessed up to 2 years
|
Estimated using the method of Kaplan and Meier.
|
From trial entry until a patient ends protocol therapy due to unacceptable toxicity, progression or death from any cause, assessed up to 2 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Correlation between RhoC expression levels and response
Zeitfenster: From baseline to up to 2 years
|
From baseline to up to 2 years
|
|
|
Change in FTAse levels
Zeitfenster: From baseline to up to 2 years
|
From baseline to up to 2 years
|
|
|
Change in the production of IL-2 and IFN-g by T cells
Zeitfenster: From baseline to up to 2 years
|
Descriptive statistics will be used to describe the mean and spread of production of IL-2 and IFN-g.
|
From baseline to up to 2 years
|
|
Adverse events as assessed by Common Toxicity Criteria (CTC) version 2.0
Zeitfenster: Up to 2 years
|
Up to 2 years
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Thomas Gajewski, Cancer and Leukemia Group B
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NCI-2012-02958
- U10CA031946 (US NIH Stipendium/Vertrag)
- CALGB-500104
- CDR0000299508
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .