Glioblastoma Multiforme
Conditions
Keywords
GBM
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.
Interventions
DRUGLucanthone
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.
DRUGTemozolomide (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.
RADIATIONRadiation
60 Gy administered in 30 fractions for 42 days in the concomitant phase.
DRUGPlacebo
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.
Sponsors
Spectrum Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 9 months | Progression Free Survival: defined as the time from randomization until objective tumor progression or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | one year | Fraction of patients with a Complete Response (CR) or Partial Response (PR) at anytime through the 12 months visit. |
| Overall Survival | one year | Overall Survival: The time from randomization until death. |
| Safety Profile of Lucanthone | one year | Safety Profile of Lucanthone at 10-15 mg/kg/day. |
Countries
India, United States
Outcome results
None listed