Phase II Trial of Ontak With Metastatic Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: Denileukin diftitox
Intervention description: 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles.
Intervention MeSH terms: Denileukin diftitox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melanoma; Metastatic; Stage IV; Ontak

Summary:

      The purpose of this study is to determine whether ONTAK is an effective treatment in patients
      with Stage IV Melanoma
    

Eligibility criteria:

        Only patients with distant metastases from cutaneous or mucosal melanoma or melanoma of
        unknown primary are eligible for this study.

          -  Only patients with distant metastases from cutaneous or mucosal melanoma or melanoma
             of unknown primary are eligible for this study. All patients must fulfill the
             following criteria:

               -  Primary tumor must be documented by histopathologic analysis

               -  Measurable disease defined as at least one lesion that can be accurately and
                  serially measured per the modified RECIST criteria (Appendix). Cutaneous lesions
                  measuring at least 1 cm will be considered measurable. Measurements must be
                  documented by radiologic examinations (CT scan, PET scan).

               -  Disease recurrences occurring greater than five years after the original
                  diagnosis must be biopsy proven.

               -  Patients with lymph node metastases in multiple lymph node beds who are not
                  amenable to surgical resection will be included in this study. Those patients
                  with involvement of a single lymph node bed are not eligible.

          -  Liver Function: Patients must have adequate hepatic function documented by a serum
             bilirubin < 1.5 x the institutional upper limit of normal and liver enzymes (SGOT or
             SGPT and LDH and alkaline phosphatase) <2X the institutional upper limit of normal
             within 28 days prior to registration.

          -  Bone Marrow Function: Patients must have an absolute granulocyte count > 1,500/ul and
             platelet count > 100,000/ul obtained within 14 days prior to registration.

          -  Renal Function: Patients must have either a serum creatinine <1.5 mg/dl or a
             calculated creatinine clearance > 75 cc/min using the following formula:

          -  Estimated Creatinine Clearance = (140-age) X WT(kg) X 0.85 (if female 0.72) X
             creatinine (mg/dl) These tests must have been performed within 28 days prior to
             registration.

          -  Patients must have a MRI of the head performed within four weeks prior to
             registration.

          -  Cardiac Function: Patients must not have a history of ventricular fibrillation, sinus
             node or AV nodal disease, Wolff Parkinson White Syndrome, evidence of congestive heart
             failure, symptoms of coronary artery disease, serious cardiac arrhythmia, or evidence
             of prior myocardial infarction on EKG. The qualifying EKG must have been performed
             prior to study registration, but no earlier than 28 days prior to the definitive
             surgery. A normal cardiac stress test within 182 days prior to randomization is
             required for all patients over 50 years old or those with abnormal EKG or any history
             of cardiac disease.

          -  Patients must not have evidence of symptomatic pulmonary disease. PFT's within 182
             days prior to registration showing a FEV1 > 2.0 liters or >75% of predicted are
             required for patients over 50 or with history of pulmonary symptoms.

          -  Patients with known autoimmune disorders, conditions of immunosuppression or treatment
             with systemic corticosteroids are not eligible for this study. Patients with known
             AIDS or HIV-1 associated complex or known to be HIV antibody seropositive are not
             eligible for this study.

          -  All patients must be 18 years of age or older.

          -  All patients must have a Zubrod Performance Status of 0 -1

          -  Patients must not be planning to receive concomitant other biologic therapy, radiation
             therapy, hormonal therapy, other chemotherapy, surgery, or other therapy while on this
             protocol.

          -  Pregnant or nursing women may not participate in this trial. Women/men of reproductive
             potential may not participate unless they have agreed to use an effective
             contraceptive method. A beta HCG pregnancy test is required within 14 days of
             registration for women of childbearing potential.

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             Stage I or II cancer from which the patient is currently in complete remission, or any
             other cancer from which the patient has been disease-free for 5 years.