Safety and Efficacy Study of Lucanthone When Used in Combination With Temozolomide(TMZ) and Radiation to Treat Glioblastoma Multiforme(GBM)

Glioblastoma Multiforme Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01587144
• Other study ID #: SPI-LUC-11-01
• Status: Terminated
• Phase: Phase 2
• Start date: June 19, 2012
• Est. completion date: April 15, 2013

Study information

• Verified date: October 2021
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: April 15, 2013
• Est. primary completion date: April 15, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• Lucanthone
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.
• Temozolomide (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.

Radiation:
• Radiation
60 Gy administered in 30 fractions for 42 days in the concomitant phase.

Drug:
• Placebo
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.

Locations

Country	Name	City	State
India	Gujarat Cancer Research Institute	Ahmedabad	Gujarat
India	Bhagwan Mahaveer Cancer Hospital & Reseach Centre	Jaipur	Rajasthan
India	Chittaranjan National Cancer Institute	Kolkata	West Bengal
India	Jaslok Hospital & Research Centre	Mumbai	Maharashtra
United States	Dent Neurologic Institute	Amherst	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	Fairview Hospital Moll Cancer Center/Cleveland Clinic	Cleveland	Ohio
United States	UCSD Moores Cancer Center	La Jolla	California
United States	Hillcrest Hospital Hirsh Cancer Center/Cleveland Clinic	Mayfield	Ohio
United States	UCI Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Progression Free Survival: defined as the time from randomization until objective tumor progression or death	9 months
Secondary	Objective response rate (ORR)	Fraction of patients with a Complete Response (CR) or Partial Response (PR) at anytime through the 12 months visit.	one year
Secondary	Overall Survival	Overall Survival: The time from randomization until death.	one year
Secondary	Safety Profile of Lucanthone	Safety Profile of Lucanthone at 10-15 mg/kg/day.	one year