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Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma
Phase 2 trial testing Plerixafor in Glioblastoma in 21 participants. Completed in 8 February 2024.
| Lead sponsor | Lawrence D Recht |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 4 December 2018 |
| Primary completion | 31 May 2022 |
| Estimated completion | 8 February 2024 |
| Sites | 1 location across United States |
Lawrence D Recht
Adults 18 to 75, any sex, with Glioblastoma or Glioblastoma With Primitive Neuronal Component. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Progression free survival will be measured at 6 months post initiation of chemoradiation. Simon 2-stage design will be use to assess progression-free survival. Will be computed from start of induction therapy and summarized with Kaplan-Meier estimates.
| Group | Value | 95% CI |
|---|---|---|
| Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy | 0.786 | 0.598 – 1.0 |
Median survival will be assessed at 31 months of subjects who have completed the 28 day Plerixafor infusion. Will be computed from start of induction therapy and summarized with Kaplan-Meier estimates.
| Group | Value | 95% CI |
|---|---|---|
| Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy | 398 | ± 0.134 |
Incidence of adverse events will be graded and recorded per Common Terminology Criteria for Adverse Events version 5.0. Will assess reported toxicities up until 30 days of treatment. The number of participants experiencing adverse events, including qualifying dose limiting toxicities (DLTs) will be tabulated by attribution (Unrelated, Unlikely to be related, Definitely related) and severity.
| Group | Value | 95% CI |
|---|---|---|
| Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy | 0 |
Patterns of Failure in patients receiving Whole Brain Radiotherapy + Plerixafor + Chemoradiotherapy was assessed by determining the out-of-field occurrence or occurrence outside of the brain over time. Local treatment failure was defined as within the 95% isodose region. Out-of-field occurrence is defined by any treatment failure observed outside treatment area.
| Group | Value | 95% CI |
|---|---|---|
| Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy | 12 |
| Group | Value | 95% CI |
|---|---|---|
| Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy | 2 |
Time frame: All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Whole Brain Radiotherapy +… |
|---|---|---|
| Depression | Psychiatric disorders | — |
| Cerebral Edema | Nervous system disorders | — |
| Pseudo Progession | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Disease Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Reaction | System | Whole Brain Radiotherapy +… |
|---|---|---|
| Nausea | Gastrointestinal Disorders | — |
| Fatigue | General Disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Vomiting | Gastrointestinal Disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Diarrhea | Gastrointestinal Disorders | — |
| Headache | Nervous System Disorders | — |
| Constipation | Gastrointestinal Disorders | — |
| Platelet count decreased | Investigations | — |
| Dizziness | Nervous System Disorders | — |
| Insomnia | Psychiatric Disorders | — |
| Chills | General Disorders | — |
| Anorexia | Metabolism and Nutrition Disorders | — |
| Cognitive disturbance | Nervous System Disorders | — |
| Pain of skin | Skin and subcutaneous tissue disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Dyspepsia | Gastrointestinal Disorders | — |
| Conjunctivitis | Infections and Infestations | — |
| Hyponatremia | Metabolism and Nutrition Disorders | — |
| Muscle weakness lower limb | Musculoskeletal and Connective Tissue Disorders | — |
| Anosmia | Nervous System Disorders | — |
| Dysgeusia | Nervous System Disorders | — |
| Imbalance | Nervous System Disorders | — |
| Paresthesia | Nervous System Disorders | — |
| Tremor | Nervous System Disorders | — |
| Delirium | Psychiatric Disorders | — |
| Suicidal ideation | Psychiatric Disorders | — |
| Anxiety | Psychiatric Disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Urticaria | Skin and subcutaneous tissue disorders | — |
| Hot flashes | Vascular Disorders | — |
| Anemia | Blood and Lymphatic System Disorders | — |
| Palpitations | Cardiac Disorders | — |
| Supraventricular Tachycardia | Cardiac Disorders | — |
| Tinnitus | Ear and Labyrinth Disorders | — |
| Hearing Impaired | Ear and Labyrinth Disorders | — |
| Floaters | Eye Disorders | — |
| Excessive Eye discharge/Rheum | Eye Disorders | — |
| Eye Irritation | Eye Disorders | — |
| Abdominal Pain | Gastrointestinal Disorders | — |
Most-reported serious reactions: Depression, Cerebral Edema, Pseudo Progession, Disease Progression.
Data from ClinicalTrials.gov NCT03746080 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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