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Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma
Phase 2 trial testing Dinutuximab in Metastatic Malignant Neoplasm in the Lung in 41 participants. Completed in 30 September 2023.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 41 |
| Start date | 4 February 2016 |
| Primary completion | 31 March 2020 |
| Estimated completion | 30 September 2023 |
| Sites | 130 locations across New Zealand, Canada, Puerto Rico, Australia, United States |
National Cancer Institute (NCI)
Under 29, any sex, with Metastatic Malignant Neoplasm in the Lung or Metastatic Osteosarcoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Patients who can be confirmed to be free of detectable disease 12 months after enrollment, without intervening disease progression, will be considered to have demonstrated 12 month disease control. All other eligible patients will be considered not to have demonstrated 12 month disease control.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Sargramostim and Dinutuximab) | 11 |
T 1/2 alpha of the serum concentration of dinutuximab in days
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Sargramostim and Dinutuximab) | 0.8 | 0.566 – 1.89 |
T 1/2 beta of the serum concentration of dinutuximab in days
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Sargramostim and Dinutuximab) | 7.5 | 7.25 – 7.86 |
Cmax of the serum concentration dinutuximab as mg/L.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Sargramostim and Dinutuximab) | 18.4 | 7.58 – 26.3 |
(AUC)0 to infinity of serum dinutuximab in mg-h/L.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Sargramostim and Dinutuximab) | 2136 | 904 – 2514 |
The number of cycles where a dose-limiting toxicity was identified where dose-limiting toxicity is defined in the protocol using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Occurrence of unacceptable toxicity as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, coded as present or absent, in each cycle received by eligible patients where all prescribed therapy for the cycle is received or the patient experiences unacceptable toxicity.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Sargramostim and Dinutuximab) | 1 |
Time frame: Through completion protocol therapy planned as 140 days after study enrollment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Sargramostim an… |
|---|---|---|
| Blurred vision | Eye disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Hallucinations | Psychiatric disorders | — |
| Eye disorders - Other, specify | Eye disorders | — |
| Photophobia | Eye disorders | — |
| Fever | General disorders | — |
| Sudden death NOS | General disorders | — |
| Serum sickness | Immune system disorders | — |
| Vascular access complication | Injury, poisoning and procedural complications | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Depressed level of consciousness | Nervous system disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Reaction | System | Treatment (Sargramostim an… |
|---|---|---|
| Hypotension | Vascular disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Capillary leak syndrome | Vascular disorders | — |
| Pain | General disorders | — |
| Allergic reaction | Immune system disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Nausea | Gastrointestinal disorders | — |
| Fever | General disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| GGT increased | Investigations | — |
| Neutrophil count decreased | Investigations | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — |
| Chest wall pain | Musculoskeletal and connective tissue disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Urticaria | Skin and subcutaneous tissue disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Non-cardiac chest pain | General disorders | — |
| Cytokine release syndrome | Immune system disorders | — |
| Serum sickness | Immune system disorders | — |
| Catheter related infection | Infections and infestations | — |
| Infections and infestations - Other, specify | Infections and infestations | — |
| Skin infection | Infections and infestations | — |
| Platelet count decreased | Investigations | — |
| Urine output decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hypoglycemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Headache | Nervous system disorders | — |
| Neuralgia | Nervous system disorders | — |
| Paresthesia | Nervous system disorders | — |
Most-reported serious reactions: Blurred vision, Vomiting, Hallucinations, Eye disorders - Other, specify, Photophobia, Fever, Sudden death NOS, Serum sickness.
Data from ClinicalTrials.gov NCT02484443 adverse events section.
This phase II trial studies how well dinutuximab works when given with sargramostim in treating patients with osteosarcoma that has come back after treatment (recurrent). Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them. Sargramostim may help the body increase the amount of white blood cells it produces, which help the body fight off infections. Giving dinutuximab with sargramostim may work better and kill more cancer cells.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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