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
18 Years
N/A
Both
Glioblastoma Multiforme
Trial Information
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
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.
Main
Inclusion Criteria:
1. 18 and 70 years of age in India, 18 years and above in US
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%.
Main Exclusion Criteria:
1. Diagnosis of recurrent brain tumor.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Description:
Progression Free Survival: defined as the time from randomization until objective tumor progression or death
Outcome Time Frame:
9 months
Safety Issue:
No
Principal Investigator
Lazlo Mechtler, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dent Neurologic Institute
Authority:
United States: Food and Drug Administration
Study ID:
SPI-LUC-11-01
NCT ID:
NCT01587144
Start Date:
March 2012
Completion Date:
June 2016
Related Keywords:
- Glioblastoma Multiforme
- GBM
- Glioblastoma
Name | Location |
|---|---|
| Cleveland Clinic | Cleveland, Ohio 44195 |
| UCI Medical Center | Irvine, California 92868 |
| UCSD Moores Cancer Center | La Jolla, California 93093 |
| Dent Neurologic Institute | Amherst, New York 14226 |
| Fairview Hospital Moll Cancer Center/Cleveland Clinic | Cleveland, Ohio 44111 |
| Hillcrest Hospital Hirsh Cancer Center/Cleveland Clinic | Mayfield, Ohio 44124 |
