Safety and Efficacy Study of Lucanthone When Used in Combination With Temozolomide(TMZ) and Radiation to Treat Glioblastoma Multiforme(GBM)
NCT ID: NCT01587144
Last Updated: 2021-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
18 participants
INTERVENTIONAL
2012-06-19
2013-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants will receive a matching placebo as an adjunct in initial six weeks of concomitant therapy with TMZ and radiation, followed by a maintenance phase of six cycles of TMZ given on Days 1 to 5 of a 28-day cycle (+/- 3 days).
Temozolomide (TMZ)
TMZ is administered at 75mg/m2 daily for 42 days during the concomitant phase. TMZ is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
Cycles 2-6: At the start of Cycle 2, the dose can be escalated to 200 mg/m2, if the common terminology criteria (CTC) nonhematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea, and vomiting), absolute neutrophil count (ANC) is ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
Radiation
60 Gy administered in 30 fractions for 42 days in the concomitant phase.
Placebo
Placebo will be given as an oral at 10-15 mg/kg/day for 6 weeks during the concomitant phase. In the maintenance phase, placebo will be administered on days 1-5 of a 28-day cycle for 6 cycles.
Lucanthone
Participants will receive Lucanthone as an adjunct in initial six weeks of concomitant therapy with TMZ and radiation, followed by a maintenance phase of six cycles of TMZ given on Days 1 to 5 of a 28-day cycle (+/- 3 days).
Lucanthone
Lucanthone will be given as an oral at 10-15 mg/kg/day for 6 weeks during the concomitant phase. In the maintenance phase, placebo will be administered on days 1-5 of a 28-day cycle for 6 cycles.
Temozolomide (TMZ)
TMZ is administered at 75mg/m2 daily for 42 days during the concomitant phase. TMZ is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
Cycles 2-6: At the start of Cycle 2, the dose can be escalated to 200 mg/m2, if the common terminology criteria (CTC) nonhematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea, and vomiting), absolute neutrophil count (ANC) is ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
Radiation
60 Gy administered in 30 fractions for 42 days in the concomitant phase.
Interventions
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Lucanthone
Lucanthone will be given as an oral at 10-15 mg/kg/day for 6 weeks during the concomitant phase. In the maintenance phase, placebo will be administered on days 1-5 of a 28-day cycle for 6 cycles.
Temozolomide (TMZ)
TMZ is administered at 75mg/m2 daily for 42 days during the concomitant phase. TMZ is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
Cycles 2-6: At the start of Cycle 2, the dose can be escalated to 200 mg/m2, if the common terminology criteria (CTC) nonhematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea, and vomiting), absolute neutrophil count (ANC) is ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
Radiation
60 Gy administered in 30 fractions for 42 days in the concomitant phase.
Placebo
Placebo will be given as an oral at 10-15 mg/kg/day for 6 weeks during the concomitant phase. In the maintenance phase, placebo will be administered on days 1-5 of a 28-day cycle for 6 cycles.
Eligibility Criteria
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Inclusion Criteria
2. Histologically proven GBM who
* May or may not have undergone surgery
* Is scheduled to receive treatment with temozolomide and radiation.
3. Karnofsky score ≥ 70%.
Exclusion Criteria
2. Received temozolomide previously.
3. Absolute neutrophil count ≤ 1.5 X 109/L.
4. Screening platelet count \< 100 K/uL.
5. Screening bilirubin \> 1.6 mg/dL.
6. Screening creatinine \> 2.25 mg/dL in men and 1.8 mg/dL in women.
7. Screening ALT or AST \> 2.5 times the upper limit of the laboratory reference range.
8. 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. Enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
10. Receiving, or plans to receive, an anti-cancer therapy other than temozolomide during the study.
11. Received prior chemotherapy or radiation therapy within four weeks of enrollment.
18 Years
ALL
No
Sponsors
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Spectrum Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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UCSD Moores Cancer Center
La Jolla, California, United States
UCI Medical Center
Orange, California, United States
Dent Neurologic Institute
Amherst, New York, United States
Fairview Hospital Moll Cancer Center/Cleveland Clinic
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Hillcrest Hospital Hirsh Cancer Center/Cleveland Clinic
Mayfield, Ohio, United States
Gujarat Cancer Research Institute
Ahmedabad, Gujarat, India
Jaslok Hospital & Research Centre
Mumbai, Maharashtra, India
Bhagwan Mahaveer Cancer Hospital & Reseach Centre
Jaipur, Rajasthan, India
Chittaranjan National Cancer Institute
Kolkata, West Bengal, India
Countries
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Other Identifiers
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SPI-LUC-11-01
Identifier Type: -
Identifier Source: org_study_id