Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance
Condition: Ciliary Body and Choroid Melanoma, Medium/Large Size; Ciliary Body and Choroid Melanoma, Small Size; Iris Melanoma; Recurrent Intraocular Melanoma
MeSH terms: Melanoma
Intervention: recombinant interferon alfa-2b; dacarbazine; laboratory biomarker analysis
Intervention description: Given subcutaneously (SC) 3 times a week for 24 weeks; Given IV on days 1 and 29; Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Dacarbazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Healthy volunteers: No

Summary:

      RATIONALE: Drugs used in chemotherapy, such as dacarbazine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Recombinant interferon alfa-2b may interfere with the growth of tumor cells. Giving
      interferon alfa-2b together with dacarbazine may be an effective treatment for primary uveal
      melanoma.

      PURPOSE: This phase II trial is studying how well giving dacarbazine together with
      recombinant interferon alfa-2b works in treating patients with primary uveal melanoma with
      genetic imbalance.
    

Eligibility criteria:

        Inclusion

          -  Patients must have a diagnosis, either cytologic or histologic, of melanoma of the
             iris, ciliary body and/or choroid

          -  Patient's tumor must exhibit monosomy 3 and/or 8q amplification as determined by
             karyotype, comparative genomic hybridization (CGH), polymerase chain reaction
             (PCR)-based microsatellite, and/or Fluorescence in situ Hybridization (FISH) analysis;
             tissue or cells for analysis can be obtained at enucleation, resection, or by fine
             needle aspirate (FNA).

          -  Patients must have undergone adequate primary therapy; this can include enucleation,
             brachytherapy, proton beam radiotherapy, stereotactic irradiation, trans-scleral local
             resection, transretinal resection or diode laser thermotherapy

          -  Patients must have had chest X-ray and hepatic ultrasound or other imaging methods
             such as CT or MRI to eliminate distant disease

          -  Patients must have a performance status (ECOG) of < 2

          -  Patients must be entered within 56 days of completing primary therapy

          -  White blood count (WBC) ≥ 3.0 x 10^9/L

          -  Neutrophils ≥ 1.5 x 10^9/L

          -  Platelets ≥ 100 x 10^9/L

          -  international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x
             upper limit of normal

          -  Hemoglobin ≥ 10 gm/100 ml

          -  Creatinine ≤ 2 mg/dl

          -  Bilirubin (total) ≤ 1.5 mg/dl

          -  Alanine transaminase (ALT) ≤ 1.5 x upper limit of normal

          -  Alkaline phosphatase ≤ 1.5 x upper limit of normal

          -  Aspartate aminotransferase (AST) ≤ 1.5 x upper limit of normal

          -  Patients must not have received any other systemic therapy for melanoma

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control) prior to study entry and for the
             duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  All patients must be informed of the investigational nature of this study and must
             provide written informed consent in accordance with institutional and federal
             guidelines; a copy of the informed consent document signed by the patient must be
             given to the patient

        Exclusion

          -  Patients with metastasis

          -  Patients that are pregnant or breastfeeding

          -  Patients may not be receiving any other investigational agents

          -  Patients with a history of immunodeficiency or autoimmune diseases are not eligible;
             patients requiring therapy with corticosteroids or other immunosuppressives are not
             eligible; patients requiring ongoing replacement therapy with physiologic doses of
             corticosteroids will be eligible.

          -  Patients with uncontrolled intercurrent illness including, but not limited to ongoing
             or active infection, symptomatic congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements are not eligible

          -  Patients who are known to be positive for HIV or Hepatitis B Surface Antigen (HepBAg)

          -  No patient may have had a malignancy other than a malignant melanoma, with the
             following exceptions: basal or squamous cell carcinomas of the skin; carcinoma in-situ
             of the uterine cervix; any malignancy treated with curative intent and in complete
             remission for > 3 years

          -  Patients with organ allografts