Temozolomide and Sorafenib in Treating Patients With Metastatic or Unresectable Melanoma

• Status: Completed
• Trial end date: 2009-07-26
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with sorafenib may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying two different schedules of temozolomide when given together with sorafenib to compare how well they work in treating patients with metastatic or unresectable melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania; University of Pennsylvania
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Niacinamide; Sorafenib; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed melanoma

• Metastatic or unresectable disease

• Measurable disease by RECIST criteria

• Cutaneous lesions measuring at least 1 cm will be considered measurable disease

• Brain metastases allowed provided patient completed radiotherapy, if radiotherapy was clinically indicated at the time of diagnosis, AND discontinued steroids prior to study enrollment

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• WBC ≥ 3,000/mm³

• Absolute granulocyte count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Serum creatinine ≤ 2.0 times upper limit of normal (ULN)

• Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN if Gilbert's disease is present)

• AST or ALT ≤ 2.5 times ULN (≤ 5.0 times ULN if liver metastases are present)

• INR ≤ 1.5 (if on anticoagulation, baseline INR must be < 1.5 before starting anticoagulation)

• PTT normal

• No other concurrent malignancies, except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or ductal or lobular carcinoma in situ of the breast

• No concurrent serious illness including, but not limited to, any of the following:

• Ongoing or active infection requiring parenteral antibiotics

• Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina)

• New York Heart Association class II-IV congestive heart failure

• Serious cardiac arrhythmia requiring medication

• Peripheral vascular disease ≥ grade II within the past year

• Psychiatric illness/social situation that would limit compliance with study requirements

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No HIV positivity

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from all prior therapy

• Prior radiotherapy allowed

• If radiotherapy has been administered to a lesion, there must be radiographic evidence of progression of that lesion for that lesion to constitute measurable disease or to be included in the measured target lesions

• Prior temozolomide or sorafenib tosylate allowed

• At least 4 weeks since prior chemotherapy

• At least 4 weeks since prior active immunotherapy (aldesleukin, interferon, sargramostim [GM-CSF], or CTLA-4)

• At least 4 weeks since prior and no other concurrent investigational anticancer therapy (except vaccines)

• No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)