Pilot Trial of "Chemo-Switch" Regimen to Treat Advanced Melanoma

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study is testing the "chemo-switch" strategy in melanoma, using biochemotherapy initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide) together with sorafenib. The purpose of this study is to find out what effects (good and bad) biochemotherapy followed by temozolomide plus sorafenib have on melanoma.

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

Details

• Lead Sponsor: Duke University
• Collaborator: Bayer
• Treatments: Dacarbazine; Sorafenib; Temozolomide

Criteria

Inclusion Criteria:

• Must have histologically or cytologically confirmed melanoma that is locally advanced or metastatic. Cutaneous, mucosal, ocular, and unknown primary melanoma are all eligible.

• Must have measurable disease, defined by RECIST as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20mm with conventional techniques or >10mm with spiral CT scan.

• May have received prior radiation therapy to one or more non-index lesions (prior radiation to an index lesion is allowable only if progression of the irradiated lesion is demonstrated, with progression defined as an increase of 20% or more in the largest diameter) and/or one prior vaccine therapy for metastatic disease. Prior adjuvant therapy with IFN alpha-2b, vaccine, and/or granulocyte-macrophage colony-stimulating factor (GM-CSF) is permitted. At least 4 weks must have elapsed since the completion of any prior therapy.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Patients must have normal organ and marrow function as defined below:

• leukocytes >3,000/uL (microliters)

• absolute neutrophil count >1,500/uL

• platelets >100,000/uL

• total bilirubin <2.0mg/dL

• AST (Aspartate transaminase)(SGOT)/ALT (Alanine transaminase)(SGPT) <2.5 X institutional upper limit of normal

• creatinine <1.8mg/dL

• If >50 years of age with one or more cardiac risk factors, must demonstrate normal exercise stress test, stress thallium test, or comparable cardiac ischemia evaluation.

• Must be at least 2 weeks out from major surgery and be free of any active infection requiring antibiotics.

• Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Women must demonstrate a negative pregnancy test prior to initiation of protocol therapy.

• Ability to understand and the willingness to sign a written informed consent form.

Exclusion Criteria:

• Prior chemotherapy, cytokine therapy (including IL-2 or IFN alpha), or antibody therapy for metastatic disease. Prior vaccine therapy is permitted.

• May not be currently receiving any other antineoplastic treatments, including chemotherapy, biologic response modifiers, radiation, vaccine, or investigational agents.

• History of brain metastases.

• Autoimmune disorders that could result in life-threatening complications in the setting of IFN alpha and IL-2 treatment.

• History of sensitivity to E. coli-derived products.

• Concurrent use of corticosteroids or any medical condition likely to require the use of systemic corticosteroids.

• A seizure disorder currently requiring anti-epileptic medication.

• Uncontrolled intercurrent illness including, but not limited to, hypertension, active infection requiring antibiotic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Evidence of bleeding diathesis.

• Currently on therapeutic anticoagulation. Prophylactic anticoagulation (such as low-dose warfarin) of venous or arterial access devices is allowed provided the PT, PTT (Partial Thromboplastin Time), and international normalized ratio (INR) are normal.