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Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery
Phase 2 trial testing peginterferon alfa-2b in Childhood Craniopharyngioma in 19 participants. Terminated before completion.
| Lead sponsor | Pediatric Brain Tumor Consortium |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 1 April 2014 |
| Primary completion | 1 December 2018 |
| Estimated completion | 1 January 2019 |
| Sites | 9 locations across United States |
Pediatric Brain Tumor Consortium
Adults 18 Months to 25, any sex, with Childhood Craniopharyngioma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The percentage of stratum 1 patients with disease stabilization at 1 year is reported, along with a 95% exact confidence interval for the estimate of the true 1-year disease stabilization rate.
| Group | Value | 95% CI |
|---|---|---|
| Stratum 1 | 28.6 | 5.3 – 65.9 |
Objective responses had to be sustained for 3 months. The percentage of participants with sustained objective responses is reported with an exact 95% confidence interval of the true sustained objective response rate.
| Group | Value | 95% CI |
|---|---|---|
| Stratum 2 | 0.0 | 0.0 – 25.0 |
Objective responses had to be sustained for 3 months. The percentage of participants with sustained objective responses is reported with an exact 95% confidence interval of the true sustained objective response rate.
| Group | Value | 95% CI |
|---|---|---|
| Stratum 1 | 14.3 | 0.01 – 55.4 |
PFS estimates for each stratum were estimated using the method of Kaplan and Meier. PFS was defined as the time interval from date on treatment to the earliest date of disease progression, second malignancy, or death; or to date of last contact for patients without events. One- and two-year PFS estimates are reported by stratum. Only eligible patients were included in this analysis (7 stratum 1 patients and 11 stratum 2 patients).
| Group | Value | 95% CI |
|---|---|---|
| Stratum 1 | 83.3 | 50.0 – 100.0 |
| Stratum 2 | 68.2 | 39.8 – 96.6 |
| Group | Value | 95% CI |
|---|---|---|
| Stratum 1 | 27.8 | 0.0 – 60.5 |
| Stratum 2 | 34.1 | 0.0 – 72.5 |
Time frame: Up to 2 years after start of treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Stratum 1 | Stratum 2 |
|---|---|---|---|
| Headache | Nervous system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Catheter related infection | Infections and infestations | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Hypernatremia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | — | — |
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Ataxia | Nervous system disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Dysarthria | Nervous system disorders | — | — |
| Encephalopathy | Nervous system disorders | — | — |
| Facial nerve disorder | Nervous system disorders | — | — |
| Somnolence | Nervous system disorders | — | — |
| Tremor | Nervous system disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Stratum 1 | Stratum 2 |
|---|---|---|---|
| Aspartate aminotransferase increased | Investigations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| White blood cell decreased | Investigations | — | — |
| Fever | General disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Fatigue | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Weight loss | Investigations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Chills | General disorders | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Hypernatremia | Metabolism and nutrition disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | — | — |
| Flu like symptoms | General disorders | — | — |
| Investigations - Other, specify | Investigations | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Blurred vision | Eye disorders | — | — |
| Floaters | Eye disorders | — | — |
| Optic nerve disorder | Eye disorders | — | — |
| Photophobia | Eye disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| General disorders and administration site conditions - Other, specify | General disorders | — | — |
| Hypothermia | General disorders | — | — |
| Injection site reaction | General disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Hyperuricemia | Metabolism and nutrition disorders | — | — |
Most-reported serious reactions: Headache, Nausea, Catheter related infection, Fall, Neutrophil count decreased, Anorexia, Hypernatremia, Hyponatremia.
Data from ClinicalTrials.gov NCT01964300 adverse events section.
This phase II trial studies how well peginterferon alfa-2b works in treating younger patients with craniopharyngioma that is recurrent or cannot be removed by surgery. Peginterferon alfa-2b may interfere with the growth of tumor cells and slow the growth of craniopharyngioma.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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