Tipifarnib in Treating Patients With Metastatic Malignant Melanoma

• Register: ClinicalTrials.gov
• Last refreshed on: 10 June 2013
• Main ID: NCT00060125
• Date of registration: 06/05/2003
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Tipifarnib in Treating Patients With Metastatic Malignant Melanoma
• Scientific title: PHASE II TRIAL OF R115777 IN PATIENTS WITH METASTATIC MALIGNANT MELANOMA
• Date of first enrolment: May 2003
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00060125
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Thomas Gajewski
• Affiliation: Cancer and Leukemia Group B

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Recurrent Melanoma

Stage IV Melanoma

Intervention(s)

Drug: tipifarnib

Other: laboratory biomarker analysis

Primary Outcome(s)

Progression-free survival (PFS) [Time Frame: From date of entry onto the trial until documented progression or death from any cause, assessed up to 2 years]

Response rate (complete response [CR] and partial response [PR]} [Time Frame: Up to 2 years]

Time to treatment failure (TTF) [Time Frame: From trial entry until a patient ends protocol therapy due to unacceptable toxicity, progression or death from any cause, assessed up to 2 years]

Secondary Outcome(s)

Adverse events as assessed by Common Toxicity Criteria (CTC) version 2.0 [Time Frame: Up to 2 years]

Change in FTAse levels [Time Frame: From baseline to up to 2 years]

Change in the production of IL-2 and IFN-g by T cells [Time Frame: From baseline to up to 2 years]

Correlation between RhoC expression levels and response [Time Frame: From baseline to up to 2 years]

Secondary ID(s)

CALGB-500104

CDR0000299508

NCI-2012-02958

U10CA031946

Source(s) of Monetary Support

Please refer to primary and secondary sponsors