Sodium Stibogluconate and IFNa-2b Followed By CDDP, VLB and DTIC Treating Pts.With Advanced Melanoma or Other Cancers

This is an interventional treatment trial for Stage IV Melanoma focused on measuring stage IV melanoma, adult anaplastic astrocytoma, adult diffuse astrocytoma, adult glioblastoma, adult giant cell glioblastoma, adult pilocytic astrocytoma, adult brain stem glioma, adult anaplastic ependymoma, adult ependymoma, adult myxopapillary ependymoma, adult subependymoma, adult anaplastic oligodendroglioma, adult oligodendroglioma, mixed gliomas, recurrent adult brain tumor, recurrent melanoma, adult gliosarcoma, adult subependymal giant cell astrocytoma, adult pineal gland astrocytoma Read More

DISEASE CHARACTERISTICS:

• Histologically confirmed melanoma or other malignancies

  • Must be refractory or resistant to established treatments OR have metastatic disease for which no effective therapy has been established

  • Gliomas or controlled CNS metastasis allowed

    • A CT scan or MRI must confirm stable brain metastases within 28 days of study entry
    • Patients with primary CNS malignancies refractory to other therapies are eligible
• Malignancy potentially responsive to sodium stibogluconate and/or interferon alfa-2b and combination chemotherapy

• Patients must have measurable or evaluable disease

  • Evaluable disease can include clinically or radiographically nonmeasurable tumor, specific tumor markers, or stage IV patients with no evidence of disease (NED)

PATIENT CHARACTERISTICS:

• Inclusion criteria:

  • ECOG performance status 0-2
  • Granulocytes > 1,500/μl
  • Platelets > 100,000/μl
  • Creatinine < 1.5 x upper limit of normal (ULN)
  • Bilirubin < 1.5 x ULN
  • AST and ALT < 1.5 x ULN (unless due to hepatic metastases)
  • Potassium ≤ 5.0 mmol/L
  • Magnesium ≤ 2.4 mg/dL
  • Creatinine clearance ≥ 60 cc/min
  • Ejection fraction ≥ 50%

• Exclusion criteria:

  • Pregnant or lactating women and fertile women or men unless surgically sterile or using effective contraception

    • All female patients of childbearing potential or less than 1 year postmenopausal must have a negative β-HCG pregnancy test at baseline and practice a medically acceptable method of birth control (i.e., oral contraceptives for at least 3 months, implantation of an intrauterine device for at least 2 months, or barrier methods [e.g., vaginal diaphragm, vaginal sponge, or condom with spermicidal jelly]) during and for 3 months after study initiation
  • History of atrial fibrillation, flutter, or other serious arrhythmia (excluding asymptomatic atrial or ventricular premature complexes) in the past 24 months
  • History of congestive heart failure currently requiring treatment; angina pectoris; or other severe cardiovascular disease (i.e., New York Heart Association class III or IV heart disease)
  • Baseline ECG abnormalities suggestive of cardiac conduction delay (i.e., first degree or greater atrio-ventricular block and/or complete or incomplete [QRS > 120 ms] bundle branch block)
  • Baseline ECG abnormalities suggestive of repolarization abnormalities (i.e., QTc ≥ 0.48 sec)

  • Culture positive acute infections requiring antibiotics within the past 14 days

    • Patients on long term suppressive antibiotic therapies are eligible
  • Known to be positive for HBsAg
  • Patients judged to not be psychologically prepared to understand informed consent or comply with an investigational study

PRIOR CONCURRENT THERAPY:

• Inclusion criteria:

  • Prior interferon therapy is allowed if administered ≥ 4 months ago
  • At least 3 weeks since prior major surgery, radiation therapy, or chemotherapy

• Exclusion criteria:

  • No prior treatment with interferon, sodium stibogluconate, cisplatin, vinblastine, or dacarbazine, except if given in an adjuvant setting
  • Patients with a prior history of solid organ allografts or allogeneic bone marrow transplant

  • Patients taking the following medications will not be eligible:

    • Amiodarone (Cordarone)
    • Disopyramide (Norpace)
    • Dofetilide (Tikosyn)
    • Procainamide (Procanbid or Pronestyl)
    • Quinidine (Quinaglute)
    • Sotalol (Betapace)
    • Erythromycin
    • Azithromycin (Z-pack)
    • Clarithromycin (Biaxin)
    • Pentamidine (Pentacarinat)
    • Trimethoprim-sulfamethoxazole (Bactrim)
    • Bepridil (Vascor)
    • Phenothiazines (e.g., prochlorperazine [Compazine], promethazine [Phenergan], or chlorpromazine [Thorazine])
    • Butyrophenones (e.g., Haloperidol [Haldol])
    • Risperidone (Risperdal)
    • Any other antipsychotic medication
    • Tricyclic or tetracyclic antidepressants (e.g., imipramine [Tofranil], amitriptyline [Elavil], desipramine [Norpramin], or nortriptyline [Pamelor])
    • Monoamine oxidase inhibitors
    • High-dose methadone
    • Arsenic trioxide
    • Dolasetron (Anzemet)
    • Any herbal preparations
  • Use of daily glucocorticoids except for physiological replacement