Biochemotherapy With Temozolomide for Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Temozolomide; Velban; Cisplatin; Interleukin-2; Intron-A; Thalidomide
Intervention description: 250 mg/m^2 By Mouth Every 4 Hours x 3 Doses On Day 1; 1.5 mg/m^2 By Vein Over 15-30 Minutes On Days 1-4; 20 mg/m^2 By Vein Over 45-120 Minutes On Days 1-4; 9 MIU/m^2 By Vein Over 24 Hours x 4 Doses On Days 1-4; 5 mu/m^2 Subcutaneously (Under the skin) Daily On Days 1-5; 400 mg By Mouth Daily
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Thalidomide; Cisplatin; Temozolomide; Interleukin-2; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: advanced stage IV melanoma; unresectable stage III melanoma; Melanoma; Temozolomide; Velban; Vinblastine; Cisplatin; Interleukin-2; Intron-A; Interferon Alpha-2b; Thalidomide; Thalomid; Temodar; Proleukin

Summary:

      The goal of this clinical research study is to learn if treatment with Temodar
      (temozolomide), Velban (vinblastine), Cisplatin, Proleukin (interleukin-2), Intron-A
      (interferon alpha), and thalidomide can help to control melanoma that has spread to other
      parts of the body. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with histologically documented diagnosis of advanced stage IV or unresectable
             stage III melanoma are eligible.

          2. They should have recurrent melanoma with measureable or evaluable sites of disease in
             order to assess the response to treatment by Response Evaluation Criteria In Solid
             Tumors (RECIST) criteria.

          3. Patients between 18 years of age and 65 years of age with an expected survival greater
             than 8 weeks and a Karnofsky performance status of 50% or better or an Eastern
             Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 will be eligible.

          4. They should have normal blood counts with a white blood count (WBC) count of more than
             or equal to 3000/mm^3 an absolute neutrophil count of more than or equal to 1500/mm^3
             and a platelet count of more than 100,000/mm^3 and have no impairment of renal
             function (serum creatinine of less than 1.6 mg/dl), hepatic function (serum bilirubin
             level of < 1.2 mg/dl) and no evidence of significant cardiac or pulmonary dysfunction.

          5. They should have no significant intercurrent illness such as an active infection,
             uncontrolled psychiatric illness, hypercalcemia (calcium > 11 mg), or active GI
             bleeding.

          6. They should not have been exposed to any previous chemotherapy or isolation perfusion
             for malignant melanoma and have had no previous exposure to interleukin-2. Prior
             adjuvant interferon is permitted. Prior radiation therapy for metastatic melanoma is
             permitted provided the patient has un-irradiated metastatic sites for response
             evaluation and has fully recovered from its toxicity.

        Exclusion Criteria:

          1. Patients with brain and/or bone metastases only.

          2. Patients with symptomatic central nervous system involvement by melanoma either as
             brain metastasis by MRI or spinal cord compression. Patients with brain metastases are
             not eligible unless their disease can be resected, it is asymptomatic, not associated
             with cerebral edema, or they are clinically stable after radiation and off
             corticosteroid therapy for 4 weeks. No major surgery or RT within 21 days before
             starting of treatment.

          3. Patients with significant cardiac illness such as symptomatic coronary artery disease
             or previous history of myocardial infarction, impaired left ventricle function (EF
             <55%) on account of any organic disease such as hypertension or valvular heart disease
             or serious cardiac arrhythmia requiring therapy. Patients with an electrocardiogram
             (EKG) disclosing an absolute QT interval >460 msec in the presence of serum potassium
             >/=4.0 mEq/L and magnesium >/= 1.8 mg/dL. Patients with heart rate less than 50.

          4. Patients with significant impairment of pulmonary function on account of chronic
             bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in
             impairment of vital capacity of Left Ventricular Ejection Fraction (FE VI) to <75% of
             predicted normal values.

          5. Patients with symptomatic effusions on account of pleural, pericardial or peritoneal
             metastases of melanoma.

          6. Patients who are unable to stay in Houston to receive therapy (first cycle) and be
             able to return for follow-up visits as required by this study.

          7. Patients with a history of second malignant tumor, other than the common skin cancers
             - basal and squamous carcinomas, within the past 5 years and uncertainty about the
             histological nature of the metastatic lesions.

          8. Patients with history of deep vein thrombi (DVT) or pulmonary embolism (PE) are
             excluded.