Clinical trial NCT01587144: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Keywords: GBM
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2012-04-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 9 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: one year
measure: Overall Survival
timeFrame: one year
measure: Safety Profile of Lucanthone
timeFrame: one year
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Orange
country: United States
facility: UCI Medical Center
state: California
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Cleveland
country: United States
facility: Fairview Hospital Moll Cancer Center/Cleveland Clinic
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Mayfield
country: United States
facility: Hillcrest Hospital Hirsh Cancer Center/Cleveland Clinic
state: Ohio
city: Ahmedabad
country: India
facility: Gujarat Cancer Research Institute
state: Gujarat
city: Mumbai
country: India
facility: Jaslok Hospital & Research Centre
state: Maharashtra
city: Jaipur
country: India
facility: Bhagwan Mahaveer Cancer Hospital & Reseach Centre
state: Rajasthan
city: Kolkata
country: India
facility: Chittaranjan National Cancer Institute
state: West Bengal
Study officials:
References: