Specialty: Cancer, Primary sub-specialty: Brain Cancer
Conditions
Interventions
Where possible trial treatment should start within 31 days of biopsy/debulking surgery. However trial treatment must start within a maximum of 42 days (6 weeks) after biopsy/surgery. Participants will
maximum duration of delivery will be 49 days (7 weeks).
2. Concurrent temozolomide 75mg/m2/day po given daily from the first to the last day of radiotherapy as per standard treatment f
increased to 200mg/m2 po on days 1-5 of cycles 2 to 6 if cycle 1 tolerated with acceptable toxicity, as per standard treatment
2. Trial treatment (each cycle): GM-CSF 50µg/day sc on da
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects with a histologically confirmed diagnosis of Glioblastoma Multiforme (WHO Grade IV, including variants). 2. Previous biopsy or debulking surgery. 3. Trial treatment must start within a maximum of 42 days (6 weeks) after biopsy/surgery. 4. Eligible for first line standard treatment with Stupp regimen (radiotherapy concomitant with temozolomide followed by adjuvant temozolomide) 5. If the participant is receiving dexamethasone (or equivalent) this must be a maximum of 8mg dexamethasone daily (or equivalent) 6. Aged over 16 7. ECOG performance status 0-1 (see appendix 2) 8. Life expectancy = 4 months 9. Required laboratory values within 7 days prior to registration 9.1. Absolute neutrophil count (ANC) = 1.5 x 109 [SI units 109/L] 9.2. Platelets =100 x109 [SI units 109/L] (without platelet transfusion) 9.3. Haemoglobin =9.0 g/dL [SI units gm/L] (with or without RBC transfusion) 9.4. Serum creatinine =1.5 x upper limit of normal (ULN) 9.5. Bilirubin =1.5 x ULN 9.6. AST/ALT =2.5 x ULN 10. Proteinuria = Grade 1 or Urinary protein < 1 g/24hr 11. Ability to provide written informed consent prior to participating in the trial and any trial-related procedures being performed. 12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and any other trial procedures. 13. Female participants of child-bearing potential must agree to use dual methods of contraception for the duration of the trial . Male participants must agree to use dual methods of contraception for the duration of the trial and for 6 months after the last dose of trial treatment is received if sexually active with a female of child-bearing potential.
Exclusion criteria
Exclusion criteria: 1. Pregnant (positive pregnancy test, serum or urine acceptable) or breast feeding 2. Previous treatment for GBM other than debulking surgery 3. Concurrent or previous malignancies ( = 12 months) of other tumours may be entered 4. Patients seropositive for HIV, Hepatitis B or C infection 5. Immunosuppressive therapy other than steroids (maximum of 8mg daily dexamethasone or equivalent) 6. Any history of hypersensitivity to any of the trial medications or excipients 7. Participants with active uncontrolled infections 8. Participants with peripheral neuropathy > = CTC grade 3 9. Poorly controlled or serious medical or psychiatric illness that, in the Investigator’s opinion, is likely to interfere with participation and/or compliance in this clinical trial 10. Patients with the following significant cardiovascular diseases within 1 year of consent; history of arrhythmia, myocardial infarction, symptomatic heart failure, uncontrolled hypertension, or history of QTc abnormalities 11. Participants must not have received G-CSF since confirmed diagnosis of Glioblastoma Multiforme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose escalation phase Dose limiting toxicities’ (DLTs) will be assessed between day 1 of chemoradiotherapy treatment and up to (but not including) day 1 of planned adjuvant chemotherapy, and will be reviewed in patient notes. Dose expansion phase Adverse events and serious adverse events will be assessed from the time of consent until 30 days post treatment. SARs and SUSARs will be assessed from the time of consent until the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety will be reported based on the occurrence of SAEs, SARs and SUSARs. Toxicity will be reported based on adverse events as graded by CTCAE V4.0. SAEs and AEs will be reported up to 30 days post treatment and SUSARs, SARs and ARs will be reported until the end of trial. 2. Progression free survival will be calculated from the date of registration to first documented evidence of disease progression or death whichever is sooner and will be reviewed in patient notes. 3. For participants with measurable disease, response is assessed using RANO criteria and is defined as the proportion of participants achieving each response category at the time of each follow-up MRI (every 84 days). This will be reviewed in patient notes. 4. Overall survival (OS) will be calculated from the date of registration to death and will be reviewed in patient notes. 5. Treatment compliance will include details of any dose reductions, delays, omissions and withdrawals. and will be reviewed in patient notes. | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactAmber;George Reid;Picard
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Outcome results
None listed