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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).
This is an international, multicenter, randomized, double blind placebo controlled phase II study to evaluate the safety and efficacy of lucanthone administered as an adjunct to patients receiving primary treatment of GBM with temozolomide and radiation. Eligible patients will be randomized to lucanthone or placebo arm in ratio of 1:1. The treatment period will be in two phases ; an initial six weeks of concomitant therapy with temozolomide and radiation, followed by a maintenance phase of six cycles of temozolomide given on Days 1 to 5 of a 28- day cycle (+/- 3 days). Lucanthone / placebo will be given as an add on in both concomitant and maintenance phases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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). |
|
| Lucanthone | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucanthone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression Free Survival: defined as the time from randomization until objective tumor progression or death | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Fraction of patients with a Complete Response (CR) or Partial Response (PR) at anytime through the 12 months visit. | one year |
| Overall Survival | Overall Survival: The time from randomization until death. |
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Main Inclusion Criteria:
18 and 70 years of age in India, 18 years and above in US
Histologically proven GBM who
Karnofsky score ≥ 70%.
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Moores Cancer Center | La Jolla | California | 92093 | United States | ||
| UCI Medical Center |
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| Temozolomide (TMZ) | Drug | 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 | Radiation | 60 Gy administered in 30 fractions for 42 days in the concomitant phase. |
|
| Placebo | Drug | 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. |
|
| one year |
| Safety Profile of Lucanthone | Safety Profile of Lucanthone at 10-15 mg/kg/day. | one year |
| Orange |
| California |
| 92868 |
| United States |
| Dent Neurologic Institute | Amherst | New York | 14226 | United States |
| Fairview Hospital Moll Cancer Center/Cleveland Clinic | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Hillcrest Hospital Hirsh Cancer Center/Cleveland Clinic | Mayfield | Ohio | 44124 | United States |
| Gujarat Cancer Research Institute | Ahmedabad | Gujarat | 380016 | India |
| Jaslok Hospital & Research Centre | Mumbai | Maharashtra | 400062 | India |
| Bhagwan Mahaveer Cancer Hospital & Reseach Centre | Jaipur | Rajasthan | 302017 | India |
| Chittaranjan National Cancer Institute | Kolkata | West Bengal | 700026 | India |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D008154 | Lucanthone |
| D000077204 | Temozolomide |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D013892 | Thioxanthenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D044004 | Xanthones |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D055585 | Physical Phenomena |
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