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SPPI 1311   |   12-197
An International, Multi-Center, Randomized, Double Blind Placebo Controlled Phase II Study to Evaluate the Safety and Efficacy of Lucanthone Administered as an Adjunct to Radiation and Temozolomide for Primary Therapy of Glioblastoma Multiforme

Main Campus
Phase 2
Temozolomide (SCH 52365)

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8:00 am - 4:30 pm, Monday - Friday

  1. Primary
    • To determine the efficacy of lucanthone when given along with temozolomide (TMZ) and radiation in the primary treatment of GBM due for radiation and TMZ treatment.
  2. Secondary
    • To evaluate the safety and toxicity of lucanthone when used in combination with temozolomide (TMZ) and radiation in primary treatment of GBM due for radiation and TMZ treatment.

Inclusion Criteria
    A patient will be eligible for study participation only if all of the following criteria apply:
  1. The patient has given informed consent. (A signed consent form that has been approved by an IRB/IEC is required prior to the performance of any protocol-related procedures or assessments)
  2. The patient is willing and able to abide by the protocol.
  3. The patient is between age 18 and 70 (both included).
  4. The patient has histologically proven GBM who a) may or may not have undergone surgery,b) is scheduled to receive treatment with temozolomide and radiation.
  5. If the patient is of childbearing potential, he/she is using an acceptable/effective method of contraception.
  6. If the patient is a female of childbearing potential, she has a negative serum pregnancy test.
  7. The patients Karnofsky score is ≥ 70%.

Exclusion Criteria
    A patient will not be eligible for study participation if any of the following criteria apply:
  1. Patient has a diagnosis of recurrent brain tumor.
  2. The patient has received temozolomide previously.
  3. The patient has an absolute neutrophil count less than or equal to 1.5 X 10^9/L.
  4. The patient has a screening platelet count less than 100 K/uL.
  5. The patient has a screening bilirubin greater than 1.6 mg/dL.
  6. The patient has a screening creatinine greater than 2.25 mg/dL in men and 1.8 mg/dL in women.
  7. The patient has a screening alanine aminotransferase (ALT), or aspartate aminotransferase (AST) greater than 2.5 times the upper limit of the laboratory reference range.
  8. The patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study.
  9. The patient is enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
  10. The patient is receiving, or plans to receive, an anti-cancer therapy other than temozolomide during the study.
  11. The patient has received prior chemotherapy or radiation therapy within four weeks of enrollment.

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