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PHASE II TRIAL OF R115777 IN PATIENTS WITH METASTATIC MALIGNANT MELANOMA


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Melanoma, Stage IV Melanoma

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Trial Information

PHASE II TRIAL OF R115777 IN PATIENTS WITH METASTATIC MALIGNANT MELANOMA


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Thomas Gajewski

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02958

NCT ID:

NCT00060125

Start Date:

May 2003

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Melanoma

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606