The purpose of the study is to determine the effectiveness of an investigational drug called
lucanthone, when combined with temozolomide (TMZ) and radiation in the treatment of
Glioblastoma Multiforme (GBM).
Drug: Temozolomide (TMZ)
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01587144
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
18 and 70 years of age in India, 18 years and above in US
Histologically proven GBM who
May or may not have undergone surgery
Is scheduled to receive treatment with temozolomide and radiation.
Karnofsky score ≥ 70%. Main
Diagnosis of recurrent brain tumor.
Received temozolomide previously.
Absolute neutrophil count ≤ 1.5 X 109/L.
Screening platelet count < 100 K/uL.
Screening bilirubin > 1.6 mg/dL.
Screening creatinine > 2.25 mg/dL in men and 1.8 mg/dL in women.
Screening ALT or AST > 2.5 times the upper limit of the laboratory reference range.
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.
Enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
Receiving, or plans to receive, an anti-cancer therapy other than temozolomide during the study.
Received prior chemotherapy or radiation therapy within four weeks of enrollment.
All locations for NCT01587144
United States (6)
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
UCI Medical Center
Orange, California, United States, 92868
Dent Neurologic Institute
Amherst, New York, United States, 14226
Cleveland, Ohio, United States, 44111
Cleveland, Ohio, United States, 44195
Hillcrest Hospital Hirsh Cancer Center/Cleveland Clinic
Mayfield, Ohio, United States, 44124
Gujarat Cancer Research Institute
Ahmedabad, Gujarat, India, 380016
Jaslok Hospital & Research Centre
Mumbai, Maharashtra, India, 400062
Bhagwan Mahaveer Cancer Hospital & Reseach Centre
Jaipur, Rajasthan, India, 302017
Chittaranjan National Cancer Institute
Kolkata, West Bengal, India, 700026
View full eligibility
Tris trial is registered with FDA with number: NCT01587144. The sponsor of the trial is Spectrum Pharmaceuticals, Inc and it is looking for 18 volunteers for the current phase.
Official trial title: 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
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