Tipifarnib in Treating Patients With Metastatic Malignant Melanoma - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00060125

Purpose

RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: This phase II trial is studying how well tipifarnib works in treating patients with metastatic malignant melanoma.

Condition	Intervention	Phase
Cutaneous Melanoma	Drug: R115777	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial of R115777 in Patients With Metastatic Malignant Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: R 115777 Tipifarnib

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:

Clinical response [ Time Frame: q 8 weeks during therapy until 8 wks post tx ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to treatment failure [ Time Frame: from study entry to 2 years post entry ] [ Designated as safety issue: No ]
RhoC Expression [ Time Frame: pre Tx and cycle 2 wk 3 ] [ Designated as safety issue: No ]
Ftase Levels [ Time Frame: pre Tx and cycle 2 wk 3 ] [ Designated as safety issue: No ]
peripheral and tumor levels will be assessed
Cytokine production by T cells [ Time Frame: pre TX and cycle 2 wk 3 ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: q cycle of Tx then q 6 mon for 2 yrs post entry ] [ Designated as safety issue: Yes ]

Enrollment:	14
Study Start Date:	May 2003
Study Completion Date:	February 2008
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: R115777 Tx of Pts with metastatic malignant melanoma with farnesyl protein transferase inhibitor	Drug: R115777 300 mg PO bid for 21 days q 28 days Other Name: tipifarnib; Zarnestra

Detailed Description:

OBJECTIVES:

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

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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060125

Locations

United States, District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Florida Hospital - Orlando
Orlando, Florida, United States, 32803
United States, Georgia
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46815
United States, Iowa
Iowa Blood and Cancer Care
Cedar Rapids, Iowa, United States, 52402
Mercy Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
St. Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Capital Region Cancer Center
Jefferson City, Missouri, United States, 65101
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13057
Community General Hospital of Greater Syracuse
Syracuse, New York, United States, 13215
Faxton Regional Cancer Center
Utica, New York, United States, 13502
United States, North Carolina
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210
United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, Tennessee
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37660

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Thomas F. Gajewski, MD, PhD

University of Chicago

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Monica M Bertagnolli, MD, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00060125 History of Changes
Other Study ID Numbers:	CDR0000299508, U10CA031946, CALGB-500104
Study First Received:	May 6, 2003
Last Updated:	March 31, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cancer and Leukemia Group B:

stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:

Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue

Nevi and Melanomas
Neoplasms by Site
Skin Diseases
Tipifarnib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012