Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Tipifarnib in Treating Patients With Metastatic Malignant Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	CALGB-500104 NCT00060125

Objectives

1. Determine clinical response in patients with metastatic malignant melanoma treated with tipifarnib.
2. Determine the safety of this drug in these patients.
3. Determine the time to treatment failure in patients treated with this drug.
4. Determine the biochemical effects of this drug on tumor tissue in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed cutaneous melanoma
  • Clinical evidence of distant, metastatic, nonresectable regional lymphatic, or extensive in-transit recurrent disease



• At least 2 cutaneous lesions amenable to excisional biopsy



• Measurable disease
  • Disease remaining after the first excisional biopsy must be measurable
  • The following are considered non-measurable disease:
    • 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 in a previously irradiated area



• No history of brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• No more than 1 prior immunotherapy regimen for advanced melanoma
  • One additional adjuvant immunologic regimen (e.g., interferon alfa) allowed
• More than 4 weeks since prior immunotherapy

Chemotherapy

• No prior chemotherapy for any stage of melanoma

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• See Disease Characteristics

Other

• No antacids (magnesium- or aluminum-containing formulations) within 2 hours of tipifarnib administration

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 mg/dL

Renal

• Creatinine no greater than 2.0 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No allergy to azole drugs (e.g., ketoconazole)
• No allergy to compounds of similar structure to tipifarnib

Expected Enrollment

A total of 14-40 patients will be accrued for this study within 2 years.

Outcomes

Clinical response
Safety
Time to treatment failure
Biochemical effects

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.

Gajewski TF, Niedzwiecki D, Johnson J, et al.: Phase II study of the farnesyltransferase inhibitor R115777 in advanced melanoma: CALGB 500104. [Abstract] J Clin Oncol 24 (Suppl 18): A-8014, 456s, 2006.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Thomas Gajewski, MD, PhD, Protocol chair		Ph: 773-702-4601; 888-824-0200 Email: tgajewsk@medicine.bsd.uchicago.edu

Registry Information
Official Title		Phase II Trial of R115777 in Patients with Metastatic Malignant Melanoma
Trial Start Date		2003-05-15
Registered in ClinicalTrials.gov		NCT00060125
Date Submitted to PDQ		2003-03-18
Information Last Verified		2005-08-11
NCI Grant/Contract Number		U10-CA31946

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