Individualized Temozolomide in Treating Patients with Stage IV Melanoma that Cannot be Removed by Surgery

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 10-008497
    NCT ID: NCT01328535
    Sponsor Protocol Number: MC1076

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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 for 2 years following end of drug administration, 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Roxana Dronca, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions