Phase 2
N=17
Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma
Glioblastoma · Glioblastoma With Primitive Neuronal Component · Gliosarcoma · Malignant Glioma · Oligodendroglial Component Present
Bottom Line
View on ClinicalTrials.gov: NCT03746080 ↗Enrolled (actual)
17
Serious AEs
17.7%
Results posted
Jun 2024
Primary outcome: Primary: Proportion of Progression Free Survival Participants (PFS) at Six Months — 0.786 Proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Plerixafor (Drug); Temozolomide (Drug); Whole-Brain Radiotherapy (WBRT) (Radiation); Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lawrence D Recht
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Progression Free Survival Participants (PFS) at Six Months |
0.786 | — |
| SECONDARY Median Survival |
398 | — |
| SECONDARY Toxicity Associated With Plerixafor/WBRT |
3; 1; 0 | — |
| SECONDARY Patterns of Treatment Failure |
12; 2 | — |
Summary
This phase II trial studies how well whole brain radiation therapy works with standard temozolomide chemo-radiotherapy and plerixafor in treating patients with glioblastoma (brain tumor). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Plerixafor is a drug that may prevent recurrence of glioblastoma after radiation treatment. Giving whole brain radiation therapy with standard temozolomide chemo-radiotherapy and plerixafor may work better in treating patients with glioblastoma.
Eligibility Criteria
Inclusion Criteria
- Patients must have tissue confirmation of high grade (World Health Organization (WHO) grade IV) glioma including but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial features, glioblastoma with primitive neuroectodermal tumor (PNET) features.
- The patient must have post-operative contrast enhanced imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) unless only biopsy performed. For patients having biopsy alone, post-operative imaging is not routinely obtained and therefore the preoperative study will serve as baseline.
- Patient should have surgery (biopsy, partial resection or gross total resection) and no additional anti-cancer therapy except the chemo-radiation as specified in the protocol.
- Patients must have Karnofsky performance score >= 60.
- Absolute neutrophil count (ANC) >= 1500 (at time of screening).
- Platelets >= 100, 000 ml (at time of screening).
- Serum creatinine = 50 mL/min (at time of screening).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 times the upper limit of normal (at time of screening).
- If female of childbearing potential, negative pregnancy test (at time of screening).
- The patient or his/her legal representative must have the ability to understand and willingness to sign a written informed consent document.
- Patient agrees to use an effective method of contraception (hormonal or two barrier methods) while on study and for at least 3 months following the plerixafor infusion.
Exclusion Criteria
- Prior or concurrent treatment with Avastin (bevacizumab).
- Prior exposure to plerixafor.
- Prior use of other investigational agents to treat the brain tumor.
- Recent history of myocardial infarct (less than 3 months) or history of active angina.
- Prior malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to 1st dose of investigational drug.
- Prior sensitivity to plerixafor.
- Pregnant or patients who are breastfeeding.
Data sourced from ClinicalTrials.gov (NCT03746080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.