- Histologically confirmed malignant melanoma that is advanced or metastatic.
- Patients may have received up to 2 prior systemic chemotherapy regimens (including
dacarbazine, and alternative dosing schedule of temozolomide). The last chemotherapy
must have been at least 4 weeks prior to study drug administration.
- Prior radiation therapy will be allowed. Radiotherapy must have been completed at
least 4 weeks prior to study drug administration.
- Patients may have received prior surgery. At least 4 weeks must have elapsed and
patients must have recovered from all side effects associated with surgery.
- Patients with measurable disease. At least one bidimensionally measurable lesion
with clearly defined margins documented by: medical photograph for skin and oral
lesions, plain X-ray with at least one diameter 0.5 cm or greater, CT, MRI, or
palpation with both diameters 2 cm or greater. A radiated bony lesion may not be
considered an evaluable lesion, unless there is evidence of disease progression at
that site prior to administration of study drug.
- Clinical parameters: Life expectancy > 2 months, Age >18 years, ECOG performance
- Patients should have adequate organ function related to the following: White count >
3000/ul, Platelet count > 70,000/ul, Hemoglobin > 8 g/l, Bilirubin WNL, AST and ALT <
2.5 x ULN, and Creatinine < 1.5 x ULN or 24 hour creatinine clearance > 60 ml/min
- There should be no acute infection requiring systemic antibiotics.
- Informed consent: Each patient must be completely aware of the nature of his/her
disease process and must willingly give consent after being informed of the procedure
to be followed, the experimental nature of the therapy, alternatives, potential
benefits, side-effects, risks, and discomforts.
- Subjects who have brain metastases.
- More than 2 prior chemotherapy regimens for the treatment of advanced melanoma.
- Chemotherapy within four weeks prior to study drug administration.
- Radiation therapy to greater than or equal to 50% of the bone marrow. Patients must
not have had prior radiotherapy to areas of measurable disease unless they have
clearly progressive disease in this site or there is measurable disease outside the
area of prior radiation.
- Insufficient recovery from all active toxicities of prior therapies.
- Subjects who are poor medical risks because of active nonmalignant systemic disease.
- Frequent vomiting or medical condition that could interfere with oral medication
intake (e.g. partial bowel obstruction).
- No prior malignancy other than curatively treated carcinoma in-situ of the cervix or
skin cancer. If in the opinion of the treating physician, sufficient time has
elapsed, such that it is extremely likely that the patient has been cured of a prior
malignancy, the patient may be eligible for the protocol.
- No serious medical or psychiatric illness preventing informed consent or intensive
treatment (e.g. serious infection). HIV status or other severe illnesses will be
assessed using medical records.
- Pregnant or nursing women. Both women and men must take adequate precautions to
prevent pregnancy during treatment.