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

• Status: Terminated
• Trial end date: 2013-04-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc
• Treatments: Dacarbazine; Lucanthone; Temozolomide

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.