NCT00060125

Brief Summary

This phase II trial is studying how well tipifarnib works in treating patients with metastatic malignant melanoma. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

3.1 years

First QC Date

May 6, 2003

Last Update Submit

June 4, 2013

Conditions

Recurrent MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (3)

  • Response rate (complete response [CR] and partial response [PR]}

    Estimated confidence intervals will be adjusted for the number of stages.

    Up to 2 years

  • Progression-free survival (PFS)

    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)

    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

Secondary Outcomes (4)

  • Correlation between RhoC expression levels and response

    From baseline to up to 2 years

  • Change in FTAse levels

    From baseline to up to 2 years

  • Change in the production of IL-2 and IFN-g by T cells

    From baseline to up to 2 years

  • Adverse events as assessed by Common Toxicity Criteria (CTC) version 2.0

    Up to 2 years

Study Arms (1)

Treatment (tipifarnib)

EXPERIMENTAL

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.

Drug: tipifarnibOther: laboratory biomarker analysis

Interventions

tipifarnibDRUG

Given orally

Also known as: R115777, Zarnestra
Treatment (tipifarnib)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (tipifarnib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

Related Publications (1)

  • Gajewski TF, Salama AK, Niedzwiecki D, Johnson J, Linette G, Bucher C, Blaskovich MA, Sebti SM, Haluska F; Cancer and Leukemia Group B. Phase II study of the farnesyltransferase inhibitor R115777 in advanced melanoma (CALGB 500104). J Transl Med. 2012 Dec 10;10:246. doi: 10.1186/1479-5876-10-246.

    PMID: 23228035DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

tipifarnib

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Thomas Gajewski

    Cancer and Leukemia Group B

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2003

First Posted

May 7, 2003

Study Start

May 1, 2003

Primary Completion

June 1, 2006

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)