Back to resultsSafety and Efficacy Study of Lucanthone When Used in Combination With Temozolomide(TMZ) and Radiation to Treat Glioblastoma Multiforme(GBM)
Primary Purpose
Glioblastoma Multiforme
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lucanthone
Temozolomide (TMZ)
Radiation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring GBM
Eligibility Criteria
Main Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
Sites / Locations
- UCSD Moores Cancer Center
- UCI Medical Center
- Dent Neurologic Institute
- Fairview Hospital Moll Cancer Center/Cleveland Clinic
- Cleveland Clinic
- Hillcrest Hospital Hirsh Cancer Center/Cleveland Clinic
- Gujarat Cancer Research Institute
- Jaslok Hospital & Research Centre
- Bhagwan Mahaveer Cancer Hospital & Reseach Centre
- Chittaranjan National Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Lucanthone
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Progression Free Survival
Progression Free Survival: defined as the time from randomization until objective tumor progression or death
Secondary Outcome Measures
Objective response rate (ORR)
Fraction of patients with a Complete Response (CR) or Partial Response (PR) at anytime through the 12 months visit.
Overall Survival
Overall Survival: The time from randomization until death.
Safety Profile of Lucanthone
Safety Profile of Lucanthone at 10-15 mg/kg/day.
Full Information
NCT ID
NCT01587144
First Posted
April 11, 2012
Last Updated
October 18, 2021
Sponsor
Spectrum Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01587144
Brief Title
Safety and Efficacy Study of Lucanthone When Used in Combination With Temozolomide(TMZ) and Radiation to Treat Glioblastoma Multiforme(GBM)
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision
Study Start Date
June 19, 2012 (Actual)
Primary Completion Date
April 15, 2013 (Actual)
Study Completion Date
April 15, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
GBM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Lucanthone
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Lucanthone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Temozolomide (TMZ)
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
60 Gy administered in 30 fractions for 42 days in the concomitant phase.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Progression Free Survival: defined as the time from randomization until objective tumor progression or death
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Fraction of patients with a Complete Response (CR) or Partial Response (PR) at anytime through the 12 months visit.
Time Frame
one year
Title
Overall Survival
Description
Overall Survival: The time from randomization until death.
Time Frame
one year
Title
Safety Profile of Lucanthone
Description
Safety Profile of Lucanthone at 10-15 mg/kg/day.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
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 Exclusion Criteria:
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.
Facility Information:
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCI Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Fairview Hospital Moll Cancer Center/Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hillcrest Hospital Hirsh Cancer Center/Cleveland Clinic
City
Mayfield
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Gujarat Cancer Research Institute
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
Jaslok Hospital & Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400062
Country
India
Facility Name
Bhagwan Mahaveer Cancer Hospital & Reseach Centre
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Chittaranjan National Cancer Institute
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700026
Country
India
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Lucanthone When Used in Combination With Temozolomide(TMZ) and Radiation to Treat Glioblastoma Multiforme(GBM)
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