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- Klinische proef NCT00060125
Tipifarnib in Treating Patients With Metastatic Malignant Melanoma
PHASE II TRIAL OF R115777 IN PATIENTS WITH METASTATIC MALIGNANT MELANOMA
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Illinois
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Chicago, Illinois, Verenigde Staten, 60606
- Cancer and Leukemia Group B
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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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Correlatieve studies
Mondeling gegeven
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Response rate (complete response [CR] and partial response [PR]}
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Correlation between RhoC expression levels and response
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to 2 years
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Up to 2 years
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Thomas Gajewski, Cancer and Leukemia Group B
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NCI-2012-02958
- U10CA031946 (Subsidie/contract van de Amerikaanse NIH)
- CALGB-500104
- CDR0000299508
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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