ReoGlio: REOLYSIN® plus GM-CSF in combination with standard of care chemotherapy and radiotherapy for patients with glioblastoma multiforme (GBM)
- Conditions
- Specialty: Cancer, Primary sub-specialty: Brain CancerUKCRC code/ Disease: Cancer/ Malignant neoplasms of eye, brain and other parts of central nervous systemCancerGlioblastoma multiforme
- Registration Number
- ISRCTN70044565
- Lead Sponsor
- niversity of Leeds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
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.
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 post end of treatment) at other sites, with the exception of appropriately treated localised epithelial skin or cervical cancer. Participants with histories (> = 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Dose escalation phase<br> 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.<br><br> Dose expansion phase<br> 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.<br>
- Secondary Outcome Measures
Name Time Method