Temodar and Sutent as Therapy for Melanoma

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

Summary

This study is designed to evaluate the safety and appropriate dose of the combination of Temodar and Sutent as first-line therapy for patients with metastatic malignant melanoma (Phase 1). Once the safety and appropriate dose is determined, additional patients will be studied at that dose to determine if there is clinical benefit as determined by the primary end-point of progression-free survival (PFS) at 6 months and additional secondary endpoints (Phase II).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northern California Melanoma Center
• Collaborators: Pfizer; Schering-Plough
• Treatments: Dacarbazine; Sunitinib; Temozolomide

Criteria

Inclusion Criteria:

• Patients with histologically confirmed, (surgically incurable or unresectable)stage IV metastatic malignant melanoma.

• Patients must not have received any prior cytokine or chemotherapy for stage IV disease.

• ECOG performance status of 0-1.

• Age greater than or equal to 18 years.

• Adequate hematologic, renal and liver function as defined by laboratory values performed within 28 days prior to initiation of dosing.

• Absolute neutrophil count (ANC) greater than or equal to 1500/uL

• Platelet count greater than or equal to 100,000/uL

• Hemoglobin greater than or equal to 10.0 g/dL

• Serum creatinine ≤ 1.5 upper limit of laboratory normal

• Total serum bilirubin less than or equal to1.5 times upper limit of laboratory normal

• LDH less than or equal to 2 times upper limit of laboratory normal

• Serum aspartate transaminase (ASAT/SGOT) or serum alanine transaminase (ALAT/SGPT) ≤ 2.5 times upper limit of laboratory normal, and ≤ 5 times upper limit of laboratory normal in cases of liver metastasis

• Patients must have recovered from effects of major surgery.

• Women of childbearing potential should be using an effective method of contraception. Women of childbearing potential must have a negative urine or serum pregnancy test up to 28 days prior to commencement of dosing and be practicing medically approved contraceptive precautions for at least 6 months after completion of treatment as directed by their physician.

• Men should use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician.

• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before trial entry.

• Before study entry, written informed consent must be obtained. Written informed consent must be obtained from the patient prior to performing any study-related procedures.

Exclusion Criteria:

• Major surgery or radiation therapy within 4 weeks of starting the study treatment.

• Evidence of brain metastases.

• NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.

• History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan.

• Any of the following within the 6 months prior to study drug administration:

myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.

• Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade equal to or greater than 2.

• Prolonged QTc interval on baseline EKG.

• Uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy).

• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.

• Known active infection.

• Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.

• Treatment with drugs with dysrhythmic potential including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, and/or indapamide.

• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

• Frequent vomiting or medical condition which could interfere with oral medication intake (e.g. partial bowel obstruction).

• Previous cancer (unless a DRS interval of at least 5 years) or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.

• Known clinically uncontrolled infectious disease including HIV positivity or AIDS-related illness.

• Pregnant or nursing.