GliomaPhase 1SAS-GKRSNCT04205357
Sulfasalazine and Stereotactic Radiosurgery for Recurrent Glioblastoma
A Phase 1 study testing Sulfasalazine in people with Glioma and Glioblastoma, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
This study evaluates the safety associated with the addition of sulfasalazine to stereotactic radiosurgery for recurrent glioblastoma. Sulfasalazine is a potential tumor selective radiosensitizer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioblastoma, Recurrent Glioblastoma
- What is being tested?
- Sulfasalazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2020to 14 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified glioblastoma multiforme with recurrence (first or second relapse, all subtypes) based on the Response Assessment in Neuro-Oncology criteria.
- Prior standard therapy for newly diagnosed glioblastoma consisting of surgery, standard fractionated radiotherapy to 60 Gy concomitant with Temozolomide
- Has been informed of other treatment options
- Must be eligible to gamma knife treatment
- Tumor size ≤ 3 cm in diameter (≤ 15 cm3 ) on MRI dated no more than 30 days before SRS treatment
- Must be at least 18 years of age
Show all 12Show fewer
- Must be ambulatory with a Karnofsky performance status of ≥ 70
- Life expectancy > 12 weeks
- Laboratory parameters for vital functions should be in the normal reference range. Laboratory abnormalities that are not clinically significant are generally permitted, except for the following laboratory parameters, which must be within the ranges specified:
- Hematology: White blood cell count: ≥ 3.0 x 109/l, Platelet count:: ≥ 100 x 109/l, Hemoglobin: ≥ 100 g/l, Total bilirubin level: <1.5 times the upper limit of normal (ULN) (except in patients with Gilbert's Syndrome who must have a total bilirubin less than 51,3 µmol/L), alanine aminotransferase < 3 times the ULN, Creatinine < 1.5 times the ULN, Normal prothrombin time / international normalized ratio (PT INR) < 1.4, Absolute neutrophil count: ≥ 1 x109/L without the support of filgrastim.
- More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less. Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the eligibility criteria.
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to national/local regulations
Who cannot join
- Allergy to sulfa drugs
- Adverse reactions to salicylates
- Known hypersensitivity to sulfasalazine, its metabolites or any of the excipients (Povidone; Maize starch; magnesium stearate; colloidal silicon dioxide)
- Eligible to alternative standard treatments with temozolomide
- Treatment with sulfasalazine after glioblastoma diagnosis
- Participation in pharmacokinetic trial within 4 weeks
Show all 18Show fewer
- Participation in immunotherapy trial within 4 weeks
- History of psychological symptoms affecting ability to consent to and/or fulfill the protocol
- Other malignant diseases and multiple sclerosis
- Pregnant or breast feeding patients.
- Porphyria
- Kidney of liver deficiencies
- Glucose-6-phosphate dehydrogenase deficiency
- Severe allergy or bronchial asthma
- History of erythema multiforme
- Significant heart failure or renal failure
- Intestinal or urinary obstruction
- Any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Trial Combining Sulfasalazine and Gamma Knife Radiosurgery for Recurrent Glioblastoma
This study evaluates the safety associated with the addition of sulfasalazine to stereotactic radiosurgery for recurrent glioblastoma. Sulfasalazine is a potential tumor selective radiosensitizer.
Read the detailed description
Glioblastoma is the most aggressive and most common type of primary brain cancer. Standard treatment at diagnosis is surgery followed by high dose radiation therapy and chemotherapy. Despite initial treatment nearly all patients will experience recurrence of the tumor with a dismal prognosis. There is no consensus on standard of care at recurrence. Reoperation is associated with a high risk of complications and further conventional radiation therapy is often not possible as the maximum tolerated dose to the normal brain has already been given. In addition most tumors have developed resistance towards chemotherapy. Stereotactic radiosurgery (SRS) may be administered despite prior initial radiation treatment but in order to avoid radiation induced complications only limited doses to limited tumor volumes can be applied.
Developing new strategies to improve the effect of radiation selectively on tumor cells without simultaneously increase the radiation induced damage of normal brain would be valuable.
The investigators have shown in experimental studies that the drug sulfasalazine enhances the number of cancer cells that dies as result of radiation therapy and thereby improves survival in combination with SRS in animals with glioblastoma. Sulfasalazine inhibits the production of an antioxidant that normally protects the tumor against radiation. Hopefully the trial will result in a new and more effective treatment option for patients with recurrent glioblastoma.
- Conditions
- Glioma, Glioblastoma, Recurrent Glioblastoma
- Being tested
- Sulfasalazine
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfasalazineDrug
Also called Stereotactic radiosurgery
Sulfasalazine combined with stereotactic radiosurgery
| Study group | Role | What they receive |
|---|---|---|
| Sulfasalazine in addition to stereotactic radiosurgery | Other | 3 + 3 dose escalation The first cohort of 3-6 patients will receive 1.5 g Sulfasalazine daily for 3 days before single fraction stereotactic radiosurgery utilizing 12 Gy prescription dose to the tumor margin.
The second, third and fourth cohort will receive 3 days pretreatment with 3 g, 4.5 g and 6 g Sulfasalazine, respectively, before 12 Gy single fraction stereotactic radiosurgery. Receives: Drug: Sulfasalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity (Common Terminology Criteria for Adverse Event v 4.0)
Determining the maximum tolerated and recommended dose of sulfasalazine as radiosensitizer.
Measured: 1 month
Secondary outcomes (7)
Intratumoral Glutathione production
Monitor the effect of sulfasalazine on the level of Glutathione production in glioma cells.
Measured: 4 days
Presence of radiation necrosis
Monitor late toxicity of sulfasalazine combined with stereotactic radiosurgery on Positron Emission Tomography.
Measured: 1 month
Progression free survival
Monitor the preliminary effect of sulfasalazine combined with stereotactic radiosurgery on local tumor control.
Measured: 1 year
Overall survival
Assess the preliminary efficacy of sulfasalazine in combination with SRS on survival.
Measured: 2 years
Quality of life (Functional Assessment of Cancer Therapy-Brain)
Assess the preliminary efficacy of sulfasalazine in combination with SRS on changes in quality of life utilizing the brain cancer subscale of the functional assessment of cancer therapy-Brain (FACT-Br) questionaire. The brain cancer subscale consists of twenty-three items regarding neurological concerns (range: 0-76 points). The response to the items uses a five-point scale ranging from 0 (not at all) to 4 (very much). The higher the patient score, the better the quality of life.
Measured: 1 year
Karnofsky performance score (KPS)
Assess the preliminary efficacy of sulfasalazine in combination with stereotactic radiosurgery on changes in the Karnofsky performance score (range 0 - 100 points). The higher the score, the better is the functional performance status of the patient.
Measured: 1 year
Steroid use in mg over time
Assess the preliminary efficacy of sulfasalazine in combination with stereotactic radiosurgery on the patients´ need for steroid medication. The change in steroid use in mg from baseline up to 1 year following radiosurgery will be evaluated using descriptive statistics.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Mar 2020
- Primary completion14 Oct 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 3 + 3 dose escalation design: Cohort 1 (3-6 patients): 1.5 gr Sulfasalazine x 1 for 3 days Cohort 2 (3-6 patients): 3.0 gr Sulfasalazine x 1 for 3 days Cohort 3 (3-6 patients): 4.5 gr SSulfasalazine x 1 for 3 days Cohort 4 (3-6 patients): 6.0 gr Sulfasalazine x 1 for 3 days
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Cancer Society, Northwell Health, Weill Medical College of Cornell University, University of Bergen, Helse Stavanger HF
- Responsible party
- Sponsor
- Investigators
- Bente S Skeie, Principal investigator, Haukeland University Hospial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205357
- Sponsor's protocol ID
- 2019/6834
- Acronym
- SAS-GKRS
- Status last verified
- Mar 2023
- First submitted
- 21 Nov 2019
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sleire L, Skeie BS, Netland IA, Forde HE, Dodoo E, Selheim F, Leiss L, Heggdal JI, Pedersen PH, Wang J, Enger PO. Drug repurposing: sulfasalazine sensitizes gliomas to gamma knife radiosurgery by blocking cystine uptake through system Xc-, leading to glutathione depletion. Oncogene. 2015 Dec 3;34(49):5951-9. doi: 10.1038/onc.2015.60. Epub 2015 Mar 23.
PubMed 25798841Skeie BS, Enger PO, Brogger J, Ganz JC, Thorsen F, Heggdal JI, Pedersen PH. gamma knife surgery versus reoperation for recurrent glioblastoma multiforme. World Neurosurg. 2012 Dec;78(6):658-69. doi: 10.1016/j.wneu.2012.03.024. Epub 2012 Apr 4.
PubMed 22484078Dodoo E, Huffmann B, Peredo I, Grinaker H, Sinclair G, Machinis T, Enger PO, Skeie BS, Pedersen PH, Ohlsson M, Orrego A, Kraepelien T, Barsoum P, Benmakhlouf H, Herrman L, Svensson M, Lippitz B. Increased survival using delayed gamma knife radiosurgery for recurrent high-grade glioma: a feasibility study. World Neurosurg. 2014 Nov;82(5):e623-32. doi: 10.1016/j.wneu.2014.06.011. Epub 2014 Jun 13.
PubMed 24930898Sontheimer H, Bridges RJ. Sulfasalazine for brain cancer fits. Expert Opin Investig Drugs. 2012 May;21(5):575-8. doi: 10.1517/13543784.2012.670634. Epub 2012 Mar 12.
PubMed 22404218Chung WJ, Lyons SA, Nelson GM, Hamza H, Gladson CL, Gillespie GY, Sontheimer H. Inhibition of cystine uptake disrupts the growth of primary brain tumors. J Neurosci. 2005 Aug 3;25(31):7101-10. doi: 10.1523/JNEUROSCI.5258-04.2005.
PubMed 16079392Skeie BS, Wang J, Dodoo E, Heggdal JI, Gronli J, Sleire L, Bragstad S, Ganz JC, Chekenya M, Mork S, Pedersen PH, Enger PO. Gamma knife surgery as monotherapy with clinically relevant doses prolongs survival in a human GBM xenograft model. Biomed Res Int. 2013;2013:139674. doi: 10.1155/2013/139674. Epub 2013 Nov 10.
PubMed 24312904Takeuchi S, Wada K, Nagatani K, Otani N, Osada H, Nawashiro H. Sulfasalazine and temozolomide with radiation therapy for newly diagnosed glioblastoma. Neurol India. 2014 Jan-Feb;62(1):42-7. doi: 10.4103/0028-3886.128280.
PubMed 24608453Robe 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 Oct 19;9:372. doi: 10.1186/1471-2407-9-372.
PubMed 19840379Skeie BS, Craig-Craven AR, Gruner ER, Biermann M, Riemer F, Bragstad S, Sarowar S, Behbahani M, Sleire L, Schwarzlmuller T, Goplen D, Heggdal JI, Knisely JPS, Schulder M, Eide GE, Filippi CG, Enger PO. Phase 1 dose-escalation trial combining sulfasalazine and stereotactic radiosurgery in patients with recurrent glioblastoma. Redox Biol. 2026 Sep;95:104241. doi: 10.1016/j.redox.2026.104241. Epub 2026 May 30.
PubMed 42229231Wang F, Oudaert I, Tu C, Maes A, Van der Vreken A, Vlummens P, De Bruyne E, De Veirman K, Wang Y, Fan R, Massie A, Vanderkerken K, Shang P, Menu E. System Xc- inhibition blocks bone marrow-multiple myeloma exosomal crosstalk, thereby countering bortezomib resistance. Cancer Lett. 2022 Jun 1;535:215649. doi: 10.1016/j.canlet.2022.215649. Epub 2022 Mar 18.
PubMed 35315341Liu N, Zhang J, Yin M, Liu H, Zhang X, Li J, Yan B, Guo Y, Zhou J, Tao J, Hu S, Chen X, Peng C. Inhibition of xCT suppresses the efficacy of anti-PD-1/L1 melanoma treatment through exosomal PD-L1-induced macrophage M2 polarization. Mol Ther. 2021 Jul 7;29(7):2321-2334. doi: 10.1016/j.ymthe.2021.03.013. Epub 2021 Mar 17.
PubMed 33744468
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial Combining Sulfasalazine and Gamma Knife Radiosurgery for Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT04205357
- Acronym / sponsor ID
- SAS-GKRS / 2019/6834
- Conditions
- Glioma, Glioblastoma, Recurrent Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Cancer Society, Northwell Health, Weill Medical College of Cornell University, University of Bergen, Helse Stavanger HF
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety associated with the addition of sulfasalazine to stereotactic radiosurgery for recurrent glioblastoma. Sulfasalazine is a potential tumor selective radiosensitizer.
Detailed description
Glioblastoma is the most aggressive and most common type of primary brain cancer. Standard treatment at diagnosis is surgery followed by high dose radiation therapy and chemotherapy. Despite initial treatment nearly all patients will experience recurrence of the tumor with a dismal prognosis. There is no consensus on standard of care at recurrence. Reoperation is associated with a high risk of complications and further conventional radiation therapy is often not possible as the maximum tolerated dose to the normal brain has already been given. In addition most tumors have developed resistance towards chemotherapy. Stereotactic radiosurgery (SRS) may be administered despite prior initial radiation treatment but in order to avoid radiation induced complications only limited doses to limited tumor volumes can be applied.
Developing new strategies to improve the effect of radiation selectively on tumor cells without simultaneously increase the radiation induced damage of normal brain would be valuable.
The investigators have shown in experimental studies that the drug sulfasalazine enhances the number of cancer cells that dies as result of radiation therapy and thereby improves survival in combination with SRS in animals with glioblastoma. Sulfasalazine inhibits the production of an antioxidant that normally protects the tumor against radiation. Hopefully the trial will result in a new and more effective treatment option for patients with recurrent glioblastoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3 + 3 dose escalation design: Cohort 1 (3-6 patients): 1.5 gr Sulfasalazine x 1 for 3 days Cohort 2 (3-6 patients): 3.0 gr Sulfasalazine x 1 for 3 days Cohort 3 (3-6 patients): 4.5 gr SSulfasalazine x 1 for 3 days Cohort 4 (3-6 patients): 6.0 gr Sulfasalazine x 1 for 3 days
| Arm | Type | Receives |
|---|---|---|
| Sulfasalazine in addition to stereotactic radiosurgery | Other | Drug: Sulfasalazine3 + 3 dose escalation The first cohort of 3-6 patients will receive 1.5 g Sulfasalazine daily for 3 days before single fraction stereotactic radiosurgery utilizing 12 Gy prescription dose to the tumor margin. The second, third and fourth cohort will receive 3 days pretreatment with 3 g, 4.5 g and 6 g Sulfasalazine, respectively, before 12 Gy single fraction stereotactic radiosurgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically verified glioblastoma multiforme with recurrence (first or second relapse, all subtypes) based on the Response Assessment in Neuro-Oncology criteria.
- Prior standard therapy for newly diagnosed glioblastoma consisting of surgery, standard fractionated radiotherapy to 60 Gy concomitant with Temozolomide
- Has been informed of other treatment options
- Must be eligible to gamma knife treatment
- Tumor size ≤ 3 cm in diameter (≤ 15 cm3 ) on MRI dated no more than 30 days before SRS treatment
Key exclusion criteria (18 listed)
- Allergy to sulfa drugs
- Adverse reactions to salicylates
- Known hypersensitivity to sulfasalazine, its metabolites or any of the excipients (Povidone; Maize starch; magnesium stearate; colloidal silicon dioxide)
- Eligible to alternative standard treatments with temozolomide
- Treatment with sulfasalazine after glioblastoma diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SulfasalazineAlso: Stereotactic radiosurgerySulfasalazine combined with stereotactic radiosurgery | Drug | Sulfasalazine in addition to stereotactic radiosurgery |
Primary outcome
Toxicity (Common Terminology Criteria for Adverse Event v 4.0)
Time frame: 1 month
Determining the maximum tolerated and recommended dose of sulfasalazine as radiosensitizer.
7 secondary outcomes
Intratumoral Glutathione production
Time frame: 4 days
Presence of radiation necrosis
Time frame: 1 month
Progression free survival
Time frame: 1 year
Overall survival
Time frame: 2 years
Quality of life (Functional Assessment of Cancer Therapy-Brain)
Time frame: 1 year
Karnofsky performance score (KPS)
Time frame: 1 year
Steroid use in mg over time
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Background: PubMed 25798841Sleire L, Skeie BS, Netland IA, Forde HE, Dodoo E, Selheim F, Leiss L, Heggdal JI, Pedersen PH, Wang J, Enger PO. Drug repurposing: sulfasalazine sensitizes gliomas to gamma knife radiosurgery by blocking cystine uptake through system Xc-, leading to glutathione depletion. Oncogene. 2015 Dec 3;34(49):5951-9. doi: 10.1038/onc.2015.60. Epub 2015 Mar 23.
- Background: PubMed 22484078Skeie BS, Enger PO, Brogger J, Ganz JC, Thorsen F, Heggdal JI, Pedersen PH. gamma knife surgery versus reoperation for recurrent glioblastoma multiforme. World Neurosurg. 2012 Dec;78(6):658-69. doi: 10.1016/j.wneu.2012.03.024. Epub 2012 Apr 4.
- Background: PubMed 24930898Dodoo E, Huffmann B, Peredo I, Grinaker H, Sinclair G, Machinis T, Enger PO, Skeie BS, Pedersen PH, Ohlsson M, Orrego A, Kraepelien T, Barsoum P, Benmakhlouf H, Herrman L, Svensson M, Lippitz B. Increased survival using delayed gamma knife radiosurgery for recurrent high-grade glioma: a feasibility study. World Neurosurg. 2014 Nov;82(5):e623-32. doi: 10.1016/j.wneu.2014.06.011. Epub 2014 Jun 13.
- Background: PubMed 22404218Sontheimer H, Bridges RJ. Sulfasalazine for brain cancer fits. Expert Opin Investig Drugs. 2012 May;21(5):575-8. doi: 10.1517/13543784.2012.670634. Epub 2012 Mar 12.
- Background: PubMed 16079392Chung WJ, Lyons SA, Nelson GM, Hamza H, Gladson CL, Gillespie GY, Sontheimer H. Inhibition of cystine uptake disrupts the growth of primary brain tumors. J Neurosci. 2005 Aug 3;25(31):7101-10. doi: 10.1523/JNEUROSCI.5258-04.2005.
- Background: PubMed 24312904Skeie BS, Wang J, Dodoo E, Heggdal JI, Gronli J, Sleire L, Bragstad S, Ganz JC, Chekenya M, Mork S, Pedersen PH, Enger PO. Gamma knife surgery as monotherapy with clinically relevant doses prolongs survival in a human GBM xenograft model. Biomed Res Int. 2013;2013:139674. doi: 10.1155/2013/139674. Epub 2013 Nov 10.
- Background: PubMed 24608453Takeuchi S, Wada K, Nagatani K, Otani N, Osada H, Nawashiro H. Sulfasalazine and temozolomide with radiation therapy for newly diagnosed glioblastoma. Neurol India. 2014 Jan-Feb;62(1):42-7. doi: 10.4103/0028-3886.128280.
- Background: PubMed 19840379Robe 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 Oct 19;9:372. doi: 10.1186/1471-2407-9-372.
- Derived from this study: PubMed 42229231Skeie BS, Craig-Craven AR, Gruner ER, Biermann M, Riemer F, Bragstad S, Sarowar S, Behbahani M, Sleire L, Schwarzlmuller T, Goplen D, Heggdal JI, Knisely JPS, Schulder M, Eide GE, Filippi CG, Enger PO. Phase 1 dose-escalation trial combining sulfasalazine and stereotactic radiosurgery in patients with recurrent glioblastoma. Redox Biol. 2026 Sep;95:104241. doi: 10.1016/j.redox.2026.104241. Epub 2026 May 30.
- Derived from this study: PubMed 35315341Wang F, Oudaert I, Tu C, Maes A, Van der Vreken A, Vlummens P, De Bruyne E, De Veirman K, Wang Y, Fan R, Massie A, Vanderkerken K, Shang P, Menu E. System Xc- inhibition blocks bone marrow-multiple myeloma exosomal crosstalk, thereby countering bortezomib resistance. Cancer Lett. 2022 Jun 1;535:215649. doi: 10.1016/j.canlet.2022.215649. Epub 2022 Mar 18.
- Derived from this study: PubMed 33744468Liu N, Zhang J, Yin M, Liu H, Zhang X, Li J, Yan B, Guo Y, Zhou J, Tao J, Hu S, Chen X, Peng C. Inhibition of xCT suppresses the efficacy of anti-PD-1/L1 melanoma treatment through exosomal PD-L1-induced macrophage M2 polarization. Mol Ther. 2021 Jul 7;29(7):2321-2334. doi: 10.1016/j.ymthe.2021.03.013. Epub 2021 Mar 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bente S Skeie principal investigator
Haukeland University Hospial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sulfasalazine in people with Glioma and Glioblastoma, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity (Common Terminology Criteria for Adverse Event v 4.0) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04205357, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.