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Safety and Efficacy Study of Lucanthone When Used in Combination With Temozolomide(TMZ) and Radiation to Treat Glioblastoma Multiforme(GBM)
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
1 other identifier
interventional
18
2 countries
10
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2012
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2012
CompletedFirst Posted
Study publicly available on registry
April 30, 2012
CompletedStudy Start
First participant enrolled
June 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2013
CompletedOctober 19, 2021
October 1, 2021
10 months
April 11, 2012
October 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Progression Free Survival: defined as the time from randomization until objective tumor progression or death
9 months
Secondary Outcomes (3)
Objective response rate (ORR)
one year
Overall Survival
one year
Safety Profile of Lucanthone
one year
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants 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 COMPARATORParticipants 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).
Interventions
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.
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.
60 Gy administered in 30 fractions for 42 days in the concomitant phase.
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
You may qualify if:
- 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%.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
UCSD Moores Cancer Center
La Jolla, California, 92093, United States
UCI Medical Center
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2012
First Posted
April 30, 2012
Study Start
June 19, 2012
Primary Completion
April 15, 2013
Study Completion
April 15, 2013
Last Updated
October 19, 2021
Record last verified: 2021-10