Sarcoma Clinical Trial
Official title:
A Phase I/IB Intergroup Trial of the HU14.18-IL2 Fusion Protein in Children With Refractory Neuroblastoma and Other GD2 Positive Tumors
RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein use different
ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I trial to study the effectiveness of hu14.18-interleukin-2 fusion protein in
treating children who have refractory or recurrent neuroblastoma or other tumors.
OBJECTIVES:
- Determine the maximum tolerated dose of hu14.18-interleukin-2 fusion protein in
children with refractory or recurrent neuroblastoma or other GD2-positive tumors.
- Determine the toxicity and pharmacokinetics of the fusion protein in these patients.
- Determine the effect of the fusion protein on systemic immune modulation in these
patients.
- Quantitate the antifusion protein antibodies in patients treated with fusion protein.
- Evaluate antitumor responses resulting from this fusion protein regimen in these
patients.
OUTLINE: This is a dose-escalation study.
Patients receive hu14.18-interleukin-2 (hu14.18-IL2) fusion protein IV over 4 hours once
daily on days 1-3. Treatment repeats every 28 days for up to 4 courses in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of hu14.18-IL2 fusion protein until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 2 months for 1 year, every 6 months for 3 years, and then
annually for 5 years.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 1 year.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04457258 -
68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma
|
Early Phase 1 | |
| Recruiting |
NCT04986748 -
Using QPOP to Predict Treatment for Sarcomas and Melanomas
|
||
| Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
| Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
| Recruiting |
NCT04535713 -
GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma
|
Phase 2 | |
| Completed |
NCT03521531 -
Burden and Medical Care of Sarcoma in Germany
|
||
| Completed |
NCT02496520 -
Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults
|
Phase 1/Phase 2 | |
| Terminated |
NCT02054104 -
Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum
|
Phase 1/Phase 2 | |
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT04577014 -
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
|
Phase 1/Phase 2 | |
| Completed |
NCT04052334 -
Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma
|
Phase 1 | |
| Completed |
NCT01593748 -
A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma
|
Phase 2 | |
| Completed |
NCT00199849 -
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|
Phase 1 | |
| Recruiting |
NCT04367779 -
Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
|
||
| Completed |
NCT01879085 -
Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04553692 -
Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers
|
Phase 1 | |
| Completed |
NCT01209598 -
PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma
|
Phase 2 | |
| Completed |
NCT04553471 -
Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers
|
N/A | |
| Withdrawn |
NCT04906876 -
A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas
|
Phase 2 |