Clinical trial · Interventional
Cediranib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
A Phase Ib/II Study of AZD2171 in Combination With Daily Temozolomide and Radiation in Patients With Newly Diagnosed Glioblastoma Not Taking Enzyme-Inducing Anti-epileptic Drugs
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I/II trial is studying the side effects and best dose of cediranib to see how well it works when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma. Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cediranib together with temozolomide and radiation therapy may kill more tumor cells.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Giant Cell Glioblastoma | Adult Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Gliosarcoma | Adult Gliosarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cediranib Maleate | Drug | Cediranib | ALIAS |
| Diffusion Tensor Imaging | Procedure | — | UNRESOLVED |
| Diffusion Weighted Imaging | Procedure | — | UNRESOLVED |
| Dynamic Contrast-Enhanced Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Fludeoxyglucose F-18 | Radiation | — | UNRESOLVED |
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Perfusion Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (enzyme inhibitor therapy, chemotherapy, IMRT)
- description
- See Detailed Description
- interventionNames
- Drug: Cediranib Maleate
- Procedure: Diffusion Tensor Imaging
- Procedure: Diffusion Weighted Imaging
- Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
- Radiation: Fludeoxyglucose F-18
- Radiation: Intensity-Modulated Radiation Therapy
- Other: Laboratory Biomarker Analysis
- Procedure: Perfusion Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
- Drug: Temozolomide
Primary outcomes (2)
- measure
- Progression-free survival (Phase II)
- timeFrame
- At day 218
- description
- The fraction of patients alive and free of disease progression after the MRI scan scheduled. This fraction will be compared, using a one sample, two-sided exact binomial test, to 50% progression-free survival (PFS). For safety assessment, the study will be powered to ensure at least 85% chance of observing a serious adverse event, if the probability of such an event on treatment were \>=5%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed glioblastoma * Newly diagnosed disease * Scheduled to receive standard post-surgical (i.e., biopsy or resection) temozolomide and radiotherapy * Must have residual, contrast-enhancing tumor (≥ 1 centimeter in ≥ 1 dimension) * Patients must be maintained on a stable corticosteroid regimen for 5 days prior to their baseline scan and for 5 days prior to their first vascular MRI; the dose of steroids should remain the same during the baseline vascular MRIs * Archival tumor tissue available for molecular analysis * No intratumoral hemorrhage or peritumoral hemorrhage by MRI * Karnofsky performance status 60-100% * Leukocytes ≥ 3,000/mcl * Absolute neutrophil count ≥ 1,500/mcL * Platelet count ≥ 100,000/mcL * Hemoglobin ≥ 8 g/dL * Total bilirubin normal * AST/ALT ≤ 2.5 times upper limit of normal * Creatinine normal OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Proteinuria ≤ 1+ on two consecutive dipsticks ≥ 7 days apart * Mini-mental status examination score ≥ 15 * Must be able to tolerate MRI and must consent to participate in additional Vascular Imaging Procedures per protocol * CT scans cannot be substituted for MRI * Mean QTc ≤ 500 msec (with Bazett's correction) by electrocardiogram * No concurrent malignancy except curatively treated basal cell or squamous cell carcinoma skin cancer or carcinoma in situ of the cervix or breast * Patients with prior malignancies must be disease-free for ≥ 5 years * No history of familial long QT syndrome or other significant ECG abnormality * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Hypertension (e.g., blood pressure \> 140/90 mm Hg) * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would preclude study compliance * No known coagulopathy that increases risk of bleeding * No history of clinically significant hemorrhages in the past * No New York Heart Association class III-IV heart disease * No condition requiring concurrent drugs or biologics with proarrhythmic potential * No other concurrent chemotherapy agents, investigational agents, or biologic therapy * No prior chemotherapy, radiotherapy, or any experimental therapy for this disease * No prior IV bevacizumab for any other medical condition * No prior carmustine implant (Gliadel Wafer) * No prior brachytherapy or radiosurgery for this disease * More than 30 days since prior and no other concurrent investigational agents or participation in an investigational therapeutic trial * At least 2 weeks since prior and no concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) * Concurrent non-EIAEDs allowed * No concurrent CYP450-inducing anticonvulsants * No concurrent anticoagulants (e.g., dalteparin, warfarin, or low-molecular weight heparin) * If patients require warfarin or other anticoagulants (e.g., low-molecular weight heparin) while on study, then patient may continue treatment * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent VEGF inhibitors * No concurrent pentamidine * No concurrent herbal or nontraditional medications
References
Publications (4)
- DERIVEDHoebel KV, Bridge CP, Ahmed S, Akintola O, Chung C, Huang RY, Johnson JM, Kim A, Ly KI, Chang K, Patel J, Pinho M, Batchelor TT, Rosen BR, Gerstner ER, Kalpathy-Cramer J. Expert-centered Evaluation of Deep Learning Algorithms for Brain Tumor Segmentation. Radiol Artif Intell. 2024 Jan;6(1):e220231. doi: 10.1148/ryai.220231. PMID 38197800
- DERIVEDHoebel KV, Patel JB, Beers AL, Chang K, Singh P, Brown JM, Pinho MC, Batchelor TT, Gerstner ER, Rosen BR, Kalpathy-Cramer J. Radiomics Repeatability Pitfalls in a Scan-Rescan MRI Study of Glioblastoma. Radiol Artif Intell. 2020 Dec 16;3(1):e190199. doi: 10.1148/ryai.2020190199. eCollection 2021 Jan. PMID 33842889
- DERIVEDEmblem KE, Farrar CT, Gerstner ER, Batchelor TT, Borra RJ, Rosen BR, Sorensen AG, Jain RK. Vessel caliber--a potential MRI biomarker of tumour response in clinical trials. Nat Rev Clin Oncol. 2014 Oct;11(10):566-84. doi: 10.1038/nrclinonc.2014.126. Epub 2014 Aug 12. PMID 25113840
- DERIVEDPinho MC, Polaskova P, Kalpathy-Cramer J, Jennings D, Emblem KE, Jain RK, Rosen BR, Wen PY, Sorensen AG, Batchelor TT, Gerstner ER. Low incidence of pseudoprogression by imaging in newly diagnosed glioblastoma patients treated with cediranib in combination with chemoradiation. Oncologist. 2014 Jan;19(1):75-81. doi: 10.1634/theoncologist.2013-0101. Epub 2013 Dec 5. PMID 24309981