Anaplastic AstrocytomaPhase 3STELLARNCT02796261
Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
A Phase 3 study testing Eflornithine and Lomustine in people with Anaplastic Astrocytoma and Recurrent Anaplastic Astrocytoma, run by Orbus Therapeutics, Inc. at 79 sites in 8 countries.
Trial summary
The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Astrocytoma, Recurrent Anaplastic Astrocytoma
- What is being tested?
- Eflornithine and Lomustine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 79 sitesin 8 countries
- Study dates
- Jul 2016to Jun 2023
- Phase
- Phase 3
- 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
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- Surgical or biopsy-proven diagnosis of WHO grade 3 AA.
- First AA tumor progression or recurrence ≤ 6 months prior to randomization based on MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors will be eligible if there is no necrosis seen on MRI and any of the following criteria is true:
- Gd-contrast lesion margins are not clearly defined,
- Gd-contrast lesions are only measurable in one dimension,
- Gd-contrast lesion has two perpendicular diameters less than 10 mm,
Show all 12Show fewer
- Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less than 20 mm and lesion does not demonstrate central necrosis,
- Recent histopathological confirmation of WHO grade 3 AA
- Received EBRT and temozolomide chemotherapy prior to first tumor progression or recurrence of WHO Grade 3 AA.
- Completion of EBRT ≥ 6 months prior to randomization.
- A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if a) pathology review confirms AA, and b) post-surgical MRI demonstrates measurable tumor on T2 FLAIR.
- Karnofsky Performance Status (KPS) score of ≥ 70.
Who cannot join
- Patients who meet any of the following exclusion criteria are not eligible for study participation:
- MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis.
- Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed.
- Prior systemic therapy for recurrence of AA.
- Presence of extracranial or leptomeningeal disease.
- Prior lomustine use.
- Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study.
- Pregnant or breastfeeding.
Trial locations and contacts
79 sites in 8 countries.
79 sites in 8 countries
United States47 sites
Piedmont Physicians Neuro-Oncology
Atlanta, Georgia, 30309
Winship Cancer Institute
Atlanta, Georgia, 30322
University of Colorado
Aurora, Colorado, 80045
Texas Oncology Austin Brain Tumor Center
Austin, Texas, 78705
University of Alabama at Birmingham
Birmingham, Alabama, 35401
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute, Brigham and Women's Hospital
Boston, Massachusetts, 02215
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina, Hollings Cancer Center
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
The Cleveland Clinic, Richard E. Jacobs Health Center
Cleveland, Ohio, 44195
OhioHealth Research and Innovation Institute
Columbus, Ohio, 43214
Neuro-Oncology Associates
Dallas, Texas, 75246
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
JFK Medical Center
Edison, New Jersey, 08820
MD Anderson Cancer Center
Houston, Texas, 77030
The University of Iowa
Iowa City, Iowa, 52242
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
HCA Midwest Division
Kansas City, Missouri, 64132
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
Kaiser Permanente
Los Angeles, California, 90027
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Norton Cancer Institute - Louisville
Louisville, Kentucky, 40202
Vanderbilt University
Nashville, Tennessee, 37232
Louisiana State University Health Sciences Center New Orleans
New Orleans, Louisiana, 70112
Mount Sinai Hospital
New York, New York, 10029
Columbia University Medical Center, The Neurological Institute
New York, New York, 10032
University of California Irvine Medical Center
Orange, California, 92868
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Providence Brain & Spine Institute
Portland, Oregon, 97225
Kaiser Permanente Center
Redwood City, California, 94063
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Kaiser Permanente
Sacramento, California, 95825
University of Utah
Salt Lake City, Utah, 84112
UCSD Moores Cancer Center
San Diego, California, 92093
University of California San Francisco Medical Center
San Francisco, California, 94143
John Wayne Cancer Institute
Santa Monica, California, 90404
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074
Swedish Health Services
Seattle, Washington, 98122
Washington University
St Louis, Missouri, 63110
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Northwestern Medicine CDH Cancer Center
Warrenville, Illinois, 60055
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
France8 sites
Institut de Cancerologie de l'Ouest - Angers
Angers, 49055
CHRU de Brest
Brest, 29200
Hôpital Pierre Wertheimer - Hospices Civils de Lyon
Bron, 69500
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Georges François Leclerc
Dijon, 21000
Hôpital Roger Salengro
Lille, 59037
Hôpital de la Timone
Marseille, 13005
Hôpital Universitaire Pitié Salpêtrière
Paris, 75013
Canada6 sites
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Center
Toronto, Ontario, M5G2M9
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
United Kingdom5 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
Edinburgh Cancer Centre - Western General Hospital
Edinburgh, EH4 2XU
Guy's Hospital
London, SE1 9RT
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
The Christie NHS Foundation Trust
Manchester, M20 4BX
Germany4 sites
Heinrich-Heine-Universitat Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Klinik und Poliklinik fur Neurologie der Universitat Regensburg
Regensburg, Bavaria, 93053
Netherlands4 sites
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, North Holland, 1081 HV
Erasmus Medisch Centrum Daniel den Hoed
Rotterdam, South Holland, 3075 EA
Sint Elisabeth Ziekenhuis
Tilburg, North Brabant, 5022 GC
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Italy3 sites
Fondazione IRCCS - Instituto Neurologico Carlo Besta
Milan, 20133
Istituto Oncologico Veneto
Padova
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
Torino, 10126
Belgium2 sites
Universitair Ziekenhuis Leuven
Leuven, Flemish Brabant, 3000
Cliniques Universitaires UCL De Mont-Godinne
Yvoir, Namur, 5530
About this study
Official title: A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.
Read the detailed description
This study will consist of 4 study periods of up to 50 months in total, consisting of:
Screening Period - A maximum screening duration of 4 weeks.
Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.
End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.
Follow-Up Period - Up to approximately 36 months, or until patient death.
A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.
- Being tested
- Eflornithine, Lomustine
- Keywords
- Anaplastic Astrocytoma, Grade 3 Glioma, Glioma, Eflornithine, Brain Cancer, Brain Tumor, Neuro-oncology, Progressive Anaplastic Astrocytoma, Recurrent Anaplastic Astrocytoma, Progressive Glioma, Recurrent Glioma, Malignant Glioma, Progressive Brain Tumor, Recurrent Brain Tumor
- Medical subject headings
- Astrocytoma, Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EflornithineDrug
Also called DFMO
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
LomustineDrug
Also called CCNU, CeeNU, Gleostine
Lomustine 90 mg/m2 administered orally once every 6 weeks
LomustineDrug
Also called CCNU, CeeNU, Gleostine
Lomustine 110 mg/m2 administered orally once every 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Eflornithine + Lomustine | Experimental | Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks Receives: Drug: Eflornithine; Drug: Lomustine |
| Lomustine | Active comparator | Lomustine dosed every 6 weeks Receives: Drug: Lomustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 4 years
Secondary outcomes (2)
Progression-free survival (PFS)
Measured: 4 years
Objective response rate (ORR)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anaplastic AstrocytomaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orbus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796261
- Sponsor's protocol ID
- OT-15-001
- Acronym
- STELLAR
- Status last verified
- Jan 2022
- First submitted
- 3 Jun 2016
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Colman H, Lombardi G, Wong ET, Walbert T, Eoli M, Lassman AB, Peereboom DM, Kizilbash SH, Kamiya-Matsuoka C, Pitz MW, Strowd RE, Desjardins A, Kumthekar P, Mason W, Pellerino A, Soffietti R, Butowski N, Forsyth PA, Hamza MA, Hau P, Lallana E, Nabors B, Piccioni D, Uhlmann EJ, Welsh LC, Wen PY, Dietrich J, Wang C, Levin VA. STELLAR: Phase III, Randomized, Open-Label Study of Eflornithine Plus Lomustine Versus Lomustine Alone in Patients With Recurrent Grade 3 Astrocytoma. J Clin Oncol. 2026 Mar 10;44(8):641-652. doi: 10.1200/JCO-25-01204. Epub 2025 Dec 1.
PubMed 41325560
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
- ClinicalTrials.gov ID
- NCT02796261
- Acronym / sponsor ID
- STELLAR / OT-15-001
- Keywords
- Anaplastic Astrocytoma, Grade 3 Glioma, Glioma, Eflornithine, Brain Cancer, Brain Tumor, Neuro-oncology, Progressive Anaplastic Astrocytoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Orbus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 10 Jun 2016 (estimated)
- 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.
The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.
Detailed description
This study will consist of 4 study periods of up to 50 months in total, consisting of:
Screening Period - A maximum screening duration of 4 weeks.
Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.
End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.
Follow-Up Period - Up to approximately 36 months, or until patient death.
A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eflornithine + Lomustine | Experimental | Drug: Eflornithine, Drug: LomustineEflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks |
| Lomustine | Active comparator | Drug: LomustineLomustine dosed every 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- Surgical or biopsy-proven diagnosis of WHO grade 3 AA.
- First AA tumor progression or recurrence ≤ 6 months prior to randomization based on MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors will be eligible if there is no necrosis seen on MRI and any of the following criteria is true:
- Received EBRT and temozolomide chemotherapy prior to first tumor progression or recurrence of WHO Grade 3 AA.
- Completion of EBRT ≥ 6 months prior to randomization.
Key exclusion criteria (8 listed)
- Patients who meet any of the following exclusion criteria are not eligible for study participation:
- MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis.
- Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed.
- Prior systemic therapy for recurrence of AA.
- Presence of extracranial or leptomeningeal disease.
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 |
|---|---|---|
| EflornithineAlso: DFMOEflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule | Drug | Eflornithine + Lomustine |
| LomustineAlso: CCNU, CeeNU, GleostineLomustine 90 mg/m2 administered orally once every 6 weeks | Drug | Eflornithine + Lomustine |
| LomustineAlso: CCNU, CeeNU, GleostineLomustine 110 mg/m2 administered orally once every 6 weeks | Drug | Lomustine |
Primary outcome
Overall survival
Time frame: 4 years
2 secondary outcomes
Progression-free survival (PFS)
Time frame: 4 years
Objective response rate (ORR)
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Derived from this study: PubMed 41325560Colman H, Lombardi G, Wong ET, Walbert T, Eoli M, Lassman AB, Peereboom DM, Kizilbash SH, Kamiya-Matsuoka C, Pitz MW, Strowd RE, Desjardins A, Kumthekar P, Mason W, Pellerino A, Soffietti R, Butowski N, Forsyth PA, Hamza MA, Hau P, Lallana E, Nabors B, Piccioni D, Uhlmann EJ, Welsh LC, Wen PY, Dietrich J, Wang C, Levin VA. STELLAR: Phase III, Randomized, Open-Label Study of Eflornithine Plus Lomustine Versus Lomustine Alone in Patients With Recurrent Grade 3 Astrocytoma. J Clin Oncol. 2026 Mar 10;44(8):641-652. doi: 10.1200/JCO-25-01204. Epub 2025 Dec 1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
79 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eflornithine and Lomustine in people with Anaplastic Astrocytoma and Recurrent Anaplastic Astrocytoma, run by Orbus Therapeutics, Inc. at 79 sites in 8 countries.
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 8 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: status not confirmed, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, France, Canada, United Kingdom, Germany and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Overall survival (time frame: 4 years). 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 NCT02796261, which also lists 1 linked publication.
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 21 Jan 2022.