Condition category
Cancer
Date applied
13/12/2005
Date assigned
15/12/2005
Last edited
15/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pierre Robe

ORCID ID

Contact details

University Hospital of Liege
University of Liege
Domaine du Sart Tilman B35
Liege
4000
Belgium
+32 (0)4 366 7209
pierre.robe@ulg.ac.be

Additional identifiers

EudraCT number

2004-004392-11

ClinicalTrials.gov number

Protocol/serial number

Ulg_GBM_04/1

Study information

Scientific title

Acronym

Study hypothesis

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

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.

Study design

A phase I - II, single centre, prospective, randomised, double blind clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase I/II

Drug names

Sulfasalazine

Primary outcome measures

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 trial start date

15/06/2005

Overall trial end date

15/06/2007

Reason abandoned

Eligibility

Participant 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 MacDonald’s 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

15/06/2005

Recruitment end date

15/06/2007

Locations

Countries of recruitment

Belgium

Trial participating centre

University Hospital of Liege
Liege
4000
Belgium

Sponsor information

Organisation

University of Liege, Department of Neurosurgery (Belgium)

Sponsor details

Domaine Universitaire du Sart Tilman
B34
Liege
4000
Belgium

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Leon Frederic Fund (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Fund for Scientific Research (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 Protocol in http://www.ncbi.nlm.nih.gov/pubmed/16448552
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19840379

Publication citations

  1. Protocol

    Robe PA, Martin D, Albert A, Deprez M, Chariot A, Bours V, A phase 1-2, prospective, double blind, randomized study of the safety and efficacy of Sulfasalazine for the treatment of progressing malignant gliomas: study protocol of [ISRCTN45828668]., BMC Cancer, 2006, 6, 29, doi: 10.1186/1471-2407-6-29.

  2. Results

    Robe PA, Martin DH, Nguyen-Khac MT, Artesi M, Deprez M, Albert A, Vanbelle S, Califice S, Bredel M, Bours V, Early termination of ISRCTN45828668, a phase 1/2 prospective, randomized study of sulfasalazine for the treatment of progressing malignant gliomas in adults., BMC Cancer, 2009, 9, 372, doi: 10.1186/1471-2407-9-372.

Additional files

Editorial Notes