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

Phase 2

Terminated

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: Temozolomide (TMZ); Drug: Lucanthone; Radiation: Radiation; Drug: Placebo

• Registration Number: NCT01587144
• Lead Sponsor: Spectrum Pharmaceuticals, Inc

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Study Start: 2012-06-19
• Primary Completion: 2013-04-15
• Study Completion: 2013-04-15
• Disposition First Submitted: 2021-09-30
• Status Verified: 2021-10
• Disposition First Submitted QC: 2021-10-08
• Disposition First Posted: 2021-10-13
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Temozolomide (TMZ)	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).
Placebo	Radiation	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).
Placebo	Placebo	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).
Lucanthone	Radiation	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).
Lucanthone	Temozolomide (TMZ)	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).
Lucanthone	Lucanthone	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).

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	9 months	Progression Free Survival: defined as the time from randomization until objective tumor progression or death

Secondary Outcome Measures

Name	Time	Method
Safety Profile of Lucanthone	one year	Safety Profile of Lucanthone at 10-15 mg/kg/day.
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.

Trial Locations

Locations (10)

Bhagwan Mahaveer Cancer Hospital & Reseach Centre; 🇮🇳 Jaipur, Rajasthan, India

Jaslok Hospital & Research Centre; 🇮🇳 Mumbai, Maharashtra, India

Gujarat Cancer Research Institute; 🇮🇳 Ahmedabad, Gujarat, India

UCSD Moores Cancer Center; 🇺🇸 La Jolla, California, United States

UCI Medical Center; 🇺🇸 Orange, California, United States

Dent Neurologic Institute; 🇺🇸 Amherst, New York, United States

Fairview Hospital Moll Cancer Center/Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Hillcrest Hospital Hirsh Cancer Center/Cleveland Clinic; 🇺🇸 Mayfield, Ohio, United States

Chittaranjan National Cancer Institute; 🇮🇳 Kolkata, West Bengal, India