Individualized Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
Condition: Recurrent Melanoma; Stage IV Melanoma
MeSH terms: Melanoma
Intervention: temozolomide; flow cytometry; staining method; biopsy; laboratory biomarker analysis
Intervention description: Given PO; Correlative studies; Correlative studies; Optional correlative studies; Correlative studies
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical trial studies individualized temozolomide (TMZ) in treating patients with stage
      IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as TMZ, work
      in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Giving TMZ at different times, which are determined individually
      for each patient based on the phase (biorhythm) of the immune system response against the
      tumor may allow for a better drug response and may kill more tumor cells
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic/cytologic proof of stage IV malignant melanoma not amenable to surgery

          -  Any number of previous chemotherapy regimens (except those containing TMZ or
             dacarbazine [DTIC]) in the metastatic setting are allowed as long as >= 4 weeks have
             elapsed from last treatment

          -  Measurable disease defined as at least one lesion whose longest diameter can be
             accurately measured as >= 1.0 cm with spiral CT scan, or ≥ 2 cm with computed
             tomography (CT) component of a positron emission tomography (PET)/CT; Note: disease
             that is measurable by physical examination only is not eligible

          -  Life expectancy of >= 3 months

          -  Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2

          -  Recovered from side effects that might interfere with the protocol therapy and: - >= 4
             weeks must have elapsed from last radiation treatment to time of study entry - >= 4
             weeks must have elapsed from the last chemotherapy administration to time of study
             entry

          -  Absolute neutrophil count (ANC) >= 1500/mL

          -  Platelet count >= 100,000/mcl

          -  Hemoglobin >= 9gm/mcl

          -  Creatinine =< 2.5 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) =< 3 x ULN

          -  Negative serum pregnancy test done =< 7 days prior to registration, for women of
             childbearing potential only

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Willingness to return to Mayo Clinic Rochester for follow-up, except for some
             appointments that can be made with the local physician

          -  Patient willing to provide research blood samples

        Exclusion Criteria:

          -  Receiving any other investigational agents including those for symptom management

          -  Uncontrolled intercurrent illness including, but not limited to, the following: -
             Active infection - Congestive heart-failure (New York Heart Association [NYHA] grade
             III or IV)

          -  Pregnant or breast feeding women, or women of child-bearing potential (and/or their
             partners) who are unwilling to utilize an approved method of birth control during the
             study and for 1 month afterward

          -  History of other malignancy < 5 years with the exception of basal cell or squamous
             cell carcinoma of the skin treated with local resection only, limited stage prostate
             cancer treated with surgery or radiation therapy with currently undetectable
             prostate-specific antigen (PSA), or carcinoma in situ of the cervix

          -  Known standard therapy for the patient's disease that is potentially curative or
             proven capable of extending life expectancy

          -  Known immunosuppression (i.e. chronic steroid use) or autoimmune disorder

          -  Human immunodeficiency virus (HIV) positive

          -  Current or known history of hepatitis

          -  Previous treatment with DTIC or TMZ

          -  Previous immunotherapy treatment for metastatic disease in the preceding 2 months;
             Note: immunotherapy in the adjuvant setting is allowed

          -  Previously untreated brain metastases; Note: patients with previously treated brain
             metastases are allowed as long as these are radiologically stable for >= 3 months and
             the patient is off steroids for >= 4 weeks