Health Condition 1: C719- Malignant neoplasm of brain, unspecified
Conditions
Interventions
Intervention1: Lucanthone (Add-on to Standard of care): Lucanthone - 150/200/250mg TID, depending on Body weight given as oral administration for 42 days in concomittant phase and 6 cycles (5 days per
Sponsors
Spectrum Pharmaceuticals Inc
OncoRx Pharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient has given informed consent. 2. The patient is willing and able to abide by the protocol. 3. The patient is between age 18 and 70 (both included). 4. The patient has histologically proven GBM who a. May or may not have undergone surgery b. Has at least one well demarcated bidimensional measurable lesion; and c. Is scheduled to receive treatment with temozolomide and radiation. 5. If the patient is of childbearing potential, he/she is using an acceptable/effective method of contraception. 6. If the patient is a female of childbearing potential, she has a negative serum pregnancy test. 7. The patientâ??s Karnofsky score is >= 70%.
Exclusion criteria
Exclusion criteria: 1. Patient has a diagnosis of recurrent brain tumor. 2. The patient has received temozolomide previously. 3. The patient has an absolute neutrophil count less than or equal to 1.5 X 109/L. 4. The patient has a screening platelet count less than 100 K/uL. 5. The patient has a screening bilirubin greater than 1.6 mg/dL. 6. The patient has a screening creatinine greater than 2.25 mg/dL in men and 1.8 mg/dL in women. 7. The patient has a screening alanine aminotransferase (ALT), or aspartate aminotransferase (AST) greater than 2.5 times the upper limit of the laboratory reference range. 8. The patient has an 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. The patient is enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product. 10. The patient is receiving, or plans to receive, an anti-cancer therapy other than temozolomide during the study. 11. The patient has received prior chemotherapy or radiation therapy within four weeks of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS)Timepoint: 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective response rate (ORR) at months 2, 4, 6, 9 and 12 2. PFS at one year 3. Overall survival at (OS) one year 4. Safety of Lucanthone given as add on to radiation and TMZ.Timepoint: 2, 4, 6, 9 and 12 months | — |
Countries
India, United States of America
Contacts
Public ContactDr Sunita Rajadhyaksha
Outcome results
None listed