Rhabdoid Tumor Clinical Trial
— NORTHOfficial title:
A Phase II Study of Panobinostat in Pediatric, Adolescent and Young Adult Patients With Solid Tumors Including Osteosarcoma, Malignant Rhabdoid Tumor/Atypical Teratoid Rhabdoid Tumors and Neuroblastoma
Verified date | June 2022 |
Source | Australian & New Zealand Children's Haematology/Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial is evaluating the anti-tumor activity and side effects of panobinostat in treating patients with osteosarcoma, malignant rhabdoid tumor/atypical teratoid rhabdoid tumor (MRT/ATRT), and neuroblastoma.
Status | Terminated |
Enrollment | 25 |
Est. completion date | December 24, 2021 |
Est. primary completion date | December 24, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 39 Years |
Eligibility | Inclusion Criteria: - Patients must be < 40 years of age. - Patient must have been histologically diagnosed with osteosarcoma, neuroblastoma or MRT/ATRT at time of diagnosis or relapse. [osteosarcoma and neuroblastoma arms are closed to recruitment]. - Patient disease is refractory to conventional therapy, in the case of osteosarcoma, neuroblastoma and MRT/ATRT or there is an absence of effective conventional therapy available in the case of ATRT. Patients must have stable disease (SD) or better following treatment with salvage therapy. - Karnofsky performance level greater than or equal to 60% for patients 16 years of age and greater, OR Lansky performance levels greater than or equal to 60% for patients less than 16 years of age. - Life expectancy of greater than 8 weeks. - Fully recovered from acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy prior to entering study. - Patients with CNS tumours who are receiving dexamethasone are on a stable/decreasing dose for at least 1 week. - Adequate BM function - Adequate renal function - Adequate liver function - Adequate cardiac function - Adequate pulmonary function - Adequate CNS function - seizure free for at least 2 months - Adequate serum calcium, magnesium and potassium concentrations - If female and post-menarchal, pregnancy test must be negative. - If of reproductive potential, have agreed to use effective contraceptive method. - If female and lactating, have agreed not to breastfeed. - Patient and/or their legal guardian have signed a written informed consent form. Exclusion Criteria: - Have received myelosuppressive chemotherapy and/or biologic therapy within 3 weeks (4 weeks if prior nitrosourea). - Have received local palliative radiotherapy within 2 weeks. - Have received craniospinal radiotherapy within 3 weeks. - Have received greater than or equal to 50% radiation of the pelvis within 6 weeks. - Have received other substantial BM radiation within 6 weeks. - Have received growth factor(s) within 1 week. - Are receiving enzyme inducing anticonvulsant therapy. - Are receiving medications associated with prolongation of QTc interval - Are receiving hydrochlorothiazide. - Are receiving metronidazole and/or disulfiram - Have uncontrolled sepsis. - Have previously received panobinostat. - Have symptoms of congestive heart failure, uncontrolled cardiac rhythm disturbance, or a QTc greater than or equal to 450msec. |
Country | Name | City | State |
---|---|---|---|
Australia | Monash Children's Hospital | Clayton | Victoria |
Australia | Royal Hobart Hospital | Hobart | Tasmania |
Australia | Perth Children's Hospital | Nedlands | Western Australia |
Australia | John Hunter Children's Hospital | New Lambton | New South Wales |
Australia | Women's and Children's Hospital | North Adelaide | South Australia |
Australia | The Royal Children's Hospital | Parkville | Victoria |
Australia | Sydney Children's Hospital | Randwick | New South Wales |
Australia | The Children's Hospital at Westmead | Westmead | New South Wales |
New Zealand | Christchurch Hospital | Christchurch | |
New Zealand | Starship Children's Hospital | Grafton | Auckland |
United States | The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Australian & New Zealand Children's Haematology/Oncology Group | National Health and Medical Research Council, Australia, Secura Bio, Inc. |
United States, Australia, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy as measured by Clinical Benefit Rate (percentage of patients with stable disease or better using MRI/CT imaging) | 4 months after intervention commencement | ||
Primary | Safety, as assessed by incidence of adverse events graded according to the NCI-CTCAE, version 4.0 | 1 week to 12 months after intervention commencement | ||
Secondary | Clinical Benefit Rate: Percentage of patients with stable disease or better using functional imaging (MIBG or FDG-PET). | Every 2 months for 12 months after treatment commencement | ||
Secondary | Time to progression calculated as the time from registration to date of event defined as the first documented progression or death resulting from underlying cancer. | 2 years after completion of treatment | ||
Secondary | Overall Survival calculated as the time from registration to date of death | 2 years after completion of treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03233204 -
Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
Active, not recruiting |
NCT03220035 -
Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
Active, not recruiting |
NCT03213678 -
Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
Recruiting |
NCT05286801 -
Tiragolumab and Atezolizumab for the Treatment of Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03213665 -
Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
Active, not recruiting |
NCT03709680 -
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT00898755 -
Collecting and Storing Tissue From Young Patients With Cancer
|
||
Withdrawn |
NCT05952687 -
Trial of Idasanutlin and Selinexor Therapy for Children With Progressive/Relapsed AT/RT or Extra-CNS Malignant Rhabdoid Tumors
|
Phase 1 | |
Completed |
NCT00179803 -
Stem Cell Transplant for High Risk Central Nervous System (CNS) Tumors
|
Phase 2 | |
Recruiting |
NCT03618381 -
EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
|
Phase 1 | |
Recruiting |
NCT04897321 -
B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)
|
Phase 1 | |
Recruiting |
NCT03155620 -
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
|
Phase 2 | |
Active, not recruiting |
NCT04483778 -
B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
|
Phase 1 | |
Terminated |
NCT02581384 -
Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT02390843 -
Simvastatin With Topotecan and Cyclophosphamide in Relapsed and/or Refractory Pediatric Solid and CNS Tumors
|
Phase 1 | |
Completed |
NCT01625351 -
A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas
|
Phase 1 | |
Recruiting |
NCT05985161 -
A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors
|
Phase 2 | |
Completed |
NCT04537715 -
Study to Describe the Interaction Between Tazemetostat and Itraconazole and Between Tazemetostat and Rifampin in Participants With Advanced Cancer
|
Phase 1 | |
Completed |
NCT01331135 -
Aflac ST0901 CHOANOME - Sirolimus in Solid Tumors
|
Phase 1 |