A phase I - II, prospective, double blind, randomised study of the safety and efficacy of sulfasalazine for the treatment of progressing malignant gliomas
| ISRCTN | ISRCTN45828668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45828668 |
| EudraCT/CTIS number | 2004-004392-11 |
| Secondary identifying numbers | Ulg_GBM_04/1 |
- Submission date
- 13/12/2005
- Registration date
- 15/12/2005
- Last edited
- 15/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Pierre Robe
Scientific
Scientific
University Hospital of Liege
University of Liege
Domaine du Sart Tilman B35
Liege
4000
Belgium
| Phone | +32 (0)4 366 7209 |
|---|---|
| pierre.robe@ulg.ac.be |
Study information
| Study design | A phase I - II, single centre, prospective, randomised, double blind clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Recent evidence suggests that the transcription factor NF-kappaB is constitutively expressed in malignant gliomas and that its inhibition by drugs like sulfasalazine may block the growth of astrocytic tumours in vitro and in experimental models of malignant gliomas. The aim of this study is to evaluate the safety and efficacy of sulfasalazine as a treatment for progressive or recurring malignant gliomas. |
| Ethics approval(s) | The protocol was reviewed and approved by the Ethics Committee of the Faculty of Medicine of the University of Liège (IRB file number 2004/185). It also underwent review and approval by Belgian Federal Authorities (authorisation reference 548/03/05) and was granted the European Trial database (EudraCT) number 2004-004392-11. |
| Health condition(s) or problem(s) studied | Progressive malignant glioma (astrocytic) |
| Intervention | The randomisation of patients between groups is provided by the Department of Statistics of the Faculty of Medicine of the University of Liège and the drug dosage is communicated only to the hospital pharmacist who prepares and delivers the drug. In order to facilitate the interim analysis of the data by the review committee, the randomisation algorithm was weighted so that 8 of the first 10 patients receive either the lowest or the highest drug dosage. Neither the investigators nor the patients are aware of the drug dosage that they provide/receive. Sulfasalazine will be given orally three times a day at total doses of 1.5, 3, 4.5 or 6 g. Four capsules of the drug are to be taken with each meal. Sulfasalazine is to be taken continuously until radiological evidence of tumour progression, complete remission, or the development of serious or intolerable adverse effects. The patient may at any moment decide to discontinue his participation to the study, although every effort will be made to be able to carry on the follow-up. Finally, the independent review committee may decide at any moment to end the study based on safety issues. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | Sulfasalazine |
| Primary outcome measure | 1. The maximal daily oral dose of sulfaslazine that is tolerated by patients with recurrent or progressive malignant gliomas. Measurements will include the nature, frequency, possible causality and severity of adverse events that occur during treatment 2. The assessment of any clinical and/or radiological response of individual tumours to sulfasalazine |
| Secondary outcome measures | Overall and progression free survival following the initiation of sulfasalazine treatment. |
| Overall study start date | 15/06/2005 |
| Completion date | 15/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Adult patients aged greater than 18 years 2. With recurrent or progressive World Health Organization (WHO) grade 3 or 4 astrocytic gliomas after surgery 3. Standard radiation therapy 4. A first line of conventional chemotherapy (e.g. temozolomide, CCNU or BCNU) Recurrence or progression prior to inclusion are based on MacDonalds criteria. Patients are thoroughly informed about the nature of their disease, suspected prognosis, study background and objectives and potential alternative treatments. This information is provided both orally and in written form, prior to obtaining written informed consent from the patient. |
| Key exclusion criteria | 1. Present with anaplastic oligodendroglioma (WHO grade 3) 2. Allergy to sulfa drugs 3. Porphyria 4. G-6-PD deficiency 5. Psychiatric disorder deemed incompatible with compliance to the study 6. Creatinine greater than 15 mg/l 7. Aspartate aminotransferase (TGO) greater than 200 UI/l 8. Amylase greater than 150 UI/l 9. Pregnant or lactating women 10. Patients may not have received any other experimental medication within 30 days (and at least five drug half-lives) prior to inclusion 11. Patients cannot concomitantly take mercaptopurine |
| Date of first enrolment | 15/06/2005 |
| Date of final enrolment | 15/06/2007 |
Locations
Countries of recruitment
- Belgium
Study participating centre
University Hospital of Liege
Liege
4000
Belgium
4000
Belgium
Sponsor information
University of Liege, Department of Neurosurgery (Belgium)
University/education
University/education
Domaine Universitaire du Sart Tilman, B34
Liege
4000
Belgium
"ROR" |
https://ror.org/00afp2z80 |
|---|
Funders
Funder type
Research organisation
Leon Frederic Fund (Belgium)
No information available
National Fund for Scientific Research (Belgium)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 31/01/2006 | Yes | No | |
| Results article | results | 19/10/2009 | Yes | No |
