Neuroblastoma RecurrentPhase 2RIST-rNB-2011NCT01467986
Multimodal Molecular Targeted Therapy to Treat Relapsed or Refractory High-risk Neuroblastoma
A Phase 2 study testing Dasatinib, Rapamycin and Irinotecan in people with Neuroblastoma Recurrent, run by University of Regensburg at 1 site in Germany.
Trial summary
Children, adolescents and young adults with high risk relapsed or treatment refractory neuroblastoma (rNB) represent a group of patients with dismal prognosis for whom a recommended standard salvage therapy is currently not available. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Neuroblastoma Recurrent
- What is being tested?
- Dasatinib, Rapamycin and Irinotecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to 30 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Pregnancy, nursing
- Patients who suffered from a thrombotic event and need anticoagulation (i.e. coumadin derivatives or low molecular weight heparin derivatives, LMWH)
- Patients with cardiac arrhythmias especially prolonged QT
- Patients with chronic inflammatory bowel diseases and/or bowel obstruction
- Patients with bilirubin serum levels 1,5 fold above the upper normal limit
- Vaccination with a live virus vaccine during the clinical trial
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- Impaired liver function and/or impaired renal function (hepatic and renal index parameter two times above normal range; see below)
- Potentially unreliable subjects, probably non compliant subjects and those judged by the investigator to be unsuitable for the study
- Doubts about the patient's cooperation
- Any contraindications or known hypersensitivity to the IMPs or to any of the other components: (see SPC ("Fachinformation", appendix)
- Known allergic reactions to the treatment medication
- Patients who were treated with radiation and/or chemotherapy for any other oncological condition
- Participation in any other phase I to III trial
- Sexually active patients who refuse to use contraception according to the institutional requirements
- Patients with extremely poor general condition (Karnofsky or Lansky score <50%)
- Neutrophil count (ANC) <500/µL, hemoglobin <8g/dL (transfusion permitted), and an unsupported platelet count <30 000/µL
- 12-lead ECG with QTc>500 msec / QTc>60 msec baseline
- Patients with hepatitis B reactivation
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Regensburg, Department of Pediatric Hematology and Oncology
Regensburg, 93053
About this study
Official title: Prospective, Open Label, Randomized Phase II Trial to Assess a Multimodal Molecular Targeted Therapy in Children, Adolescent and Young Adults With Relapsed or Refractory High-risk Neuroblastoma
Children, adolescents and young adults with high risk relapsed or treatment refractory neuroblastoma (rNB) represent a group of patients with dismal prognosis for whom a recommended standard salvage therapy is currently not available.
The multimodal metronomic approach combining molecular targeted drugs (rapamycin and dasatinib) with conventional chemotherapy (irinotecan and temozolomide) will be investigated in a randomized fashion as new treatment strategy for patients with rNB. The intention is to assess the therapeutic benefit of molecular targeted drugs for the treatment of rNB.
Read more
The combination of irinotecan and temozolomide showed activity in the treatment of several solid organ tumors, brain tumors and neuroblastoma. In one study rNB patients received a median of 5 courses of 5 days irinotecan and temozolomide every 3 to 4 weeks with a cumulative dose of 35% lower than in the RIST design. 33% had disease regression with 8% CR or PR. A phase II study in rNB also using irinotecan and temozolomide with a substantially lower intensity showed a response rate of 15%.
The combination of a mTOR inhibitor with a multi-kinase inhibitor demonstrated in preclinical studies a synergistic effect on cell cycle arrest, apoptosis and sensitization for radio- and chemotherapy. It is assumed that this combination of molecular targeted drugs with a tolerable conventional chemotherapy consisting of irinotecan and temozolomide can substantially improve the outcome of this patient population. A group of 20 rNB patients treated with the RIST therapy approach in a compassionate use setting showed an overall survival of 55% at a median of 80 weeks with a tolerable adverse event profile.
- Conditions
- Neuroblastoma Recurrent
- Being tested
- Dasatinib, Rapamycin, Irinotecan, Temozolomide
- Keywords
- neuroblastoma, molecular targeted therapy, protein kinase inhibitor, mTOR Inhibitor, cytostatic topoisomerase-I-inhibitor, temozolomide, irinotecan, dasatinib, rapamycin
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called Sprycel®
Pharmacotherapeutic Group: protein kinase inhibitor ATC-Code: L01XE06 Excipients: Tablet core: Lactose monohydrate, Cellulose, microcrystalline, Croscarmellose sodium, Hydroxypropyl cellulose, Magnesium stearate. Film-coating: Hypromellose, Titanium dioxide, Macrogol 400 Formulation: film coated tablet Route of Administration: orally. Patients should be instructed to swallow the tablets as a whole and not to split, chew, or crush them.
RapamycinDrug
Also called Rapamune®
Pharmacotherapeutic Group: Immunosuppressive agents - mTOR Inhibitors ATC-Code: L04A A10 Excipients: Polysorbat 80, Phosal 50 PG ((3-sn-Phosphatidyl)cholin from Soy beans, Propylenglycol, lipid acid mono- and -diglyzeride from Soy oil, Ethanol (1,5% bis 2,5%), Soy liid acid and Palmitoyl ascorbic acid) Formulation: Oral solution Route of Administration:orally
IrinotecanDrug
Also called Irinomedac®
Pharmacotherapeutic Group: cytostatic topoisomerase-I-inhibitor ATC-Code: L01XX19 Excipients: Sorbitol (E420), lactic acid, sodium hydroxid (to adjust the pH to 3.5), water for injection Formulation: concentrate for solution for infusion Route of Administration: intravenously
TemozolomideDrug
Also called Temomedac®
Pharmacotherapeutic Group: Antineoplastic agents - Other alkylating agents, ATC-Code: L01A X03 Excipients: Capsule content: Anhydrous lactose, Sodium starch glycolate Type A, Colloida anhydrous silica, Tartaric acid, Stearic acid. Capsule shell: Gelatine, Titanium dioxide (E171).
Printing ink: Shellac Propylene glycol, Titanium dioxide (E171), Sunset yellow FCF Aluminium Lake (E110) Formulation: capsule, hard Route of Administration: orally; Temomedac hard capsules should be administered in the fasting state. The capsules must be swallowed whole with a glass of water and must not be opened or chewed
IrinotecanDrug
Also called Irinomedac®
Pharmacotherapeutic Group: cytostatic topoisomerase-I-inhibitor ATC-Code: L01XX19 Excipients: Sorbitol (E420), lactic acid, sodium hydroxid (to adjust the pH to 3.5), water for injection Formulation: concentrate for solution for infusion Route of Administration: intravenously
TemozolomideDrug
Also called Temomedac®
Pharmacotherapeutic Group: Antineoplastic agents - Other alkylating agents, ATC-Code: L01A X03 Excipients: Capsule content: Anhydrous lactose, Sodium starch glycolate Type A, Colloida anhydrous silica, Tartaric acid, Stearic acid. Capsule shell: Gelatine, Titanium dioxide (E171).
Printing ink: Shellac Propylene glycol, Titanium dioxide (E171), Sunset yellow FCF Aluminium Lake (E110) Formulation: capsule, hard Route of Administration: orally; Temomedac hard capsules should be administered in the fasting state. The capsules must be swallowed whole with a glass of water and must not be opened or chewed
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan, Temozolomide | Active comparator | Patients randomized to the control arm receive irinotecan (I) and temozolomide (T) alone. Receives: Drug: Temozolomide; Drug: Irinotecan |
| Rapamycin, Dasatinib, Temozolomide, Irinotecan | Experimental | Patients with rNB receive on the study arm the experimental combination of rapamycin (R)- mTOR Inhibitor, dasatinib (D)- protein kinase inhibitor irinotecan (I)- cytostatic topoisomerase-I-inhibitor and temozolomide (T)- Antineoplastic agent Receives: Drug: Dasatinib; Drug: Rapamycin; Drug: Irinotecan; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is progression-free survival (PFS)
The primary objective of this trial is the evaluation of progression-free survival of rNB in children, adolescents and young adults, comparing a multimodal treatment regimen consisting of temozolomide (T), irinotecan (I), rapamycin (R) and dasatinib (S) against irinotecan (I) and temozolomide (T) (I/T) alone
Measured: Time interval from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks
Secondary outcomes (8)
Overall survival (OS)
Measured: Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Response to the investigational treatment after 4 and 8 courses of I/T and 1-year-follow-up in the RIST treatment arm
Measured: Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Duration until adequate response to this treatment regimen
Measured: Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Assessment of quality of life (Lansky and Karnofsky Scores)
Measured: • Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Toxicity of this combination of drugs in children, adolescents and young adults with rNB
Assessment according to the latest version of the CTC criteria. In particular due to the expected AE Profile:
- Myelosuppressive measures (RBC, PLT units)
- Infectious complications
- Gastrointestinal problems
Measured: From the first course of the investigational treatment up to the end of the trial assessed to 52 weeks.
Safety and tolerability of the investigational treatment
Assessment according to the latest version of the CTC criteria. In particular due to the expected AE Profile:
- Myelosuppressive measures (RBC, PLT units)
- Infectious complications
- Gastrointestinal problems
Measured: Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Assessment of the prognostic relevance of International Neuroblastoma Risk Group (INRG) classification system on the event free survival
Measured: Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Prognostic relevance of defined factors on the event free survival in this patient population (i.e. response assessment of HVA, VMA, NSE)
Measured: Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startAug 2013
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroblastoma RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Selim Corbacioglu, University of Regensburg
- Investigators
- Selim Corbacioglu, MD, Principal investigator, University of Regensburg, Department of Pediatric Hematology and Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467986
- Sponsor's protocol ID
- RIST-rNB-2011
- Acronym
- RIST-rNB-2011
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2011
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Corbacioglu S, Lode H, Ellinger S, Zeman F, Suttorp M, Escherich G, Bochennek K, Gruhn B, Lang P, Rohde M, Debatin KM, Steinbach D, Beilken A, Ladenstein R, Spachtholz R, Heiss P, Hellwig D, Troger A, Koller M, Menhart K, Riemenschneider MJ, Zoubaa S, Kietz S, Jakob M, Sommer G, Heise T, Hundsdorfer P, Kuhnle I, Dilloo D, Schonberger S, Schwabe G, von Luettichau I, Graf N, Schlegel PG, Fruhwald M, Jorch N, Paulussen M, Schneider DT, Metzler M, Leipold A, Nathrath M, Imschweiler T, Christiansen H, Schmid I, Crazzolara R, Niktoreh N, Cario G, Faber J, Demmert M, Babor F, Frohlich B, Bielack S, Bernig T, Greil J, Eggert A, Simon T, Foell J. Irinotecan and temozolomide in combination with dasatinib and rapamycin versus irinotecan and temozolomide for patients with relapsed or refractory neuroblastoma (RIST-rNB-2011): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet Oncol. 2024 Jul;25(7):922-932. doi: 10.1016/S1470-2045(24)00202-X.
PubMed 38936379
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Label, Randomized Phase II Trial to Assess a Multimodal Molecular Targeted Therapy in Children, Adolescent and Young Adults With Relapsed or Refractory High-risk Neuroblastoma
- ClinicalTrials.gov ID
- NCT01467986
- Acronym / sponsor ID
- RIST-rNB-2011 / RIST-rNB-2011
- Conditions
- Neuroblastoma Recurrent
- Keywords
- neuroblastoma, molecular targeted therapy, protein kinase inhibitor, mTOR Inhibitor, cytostatic topoisomerase-I-inhibitor, temozolomide, irinotecan, dasatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children, adolescents and young adults with high risk relapsed or treatment refractory neuroblastoma (rNB) represent a group of patients with dismal prognosis for whom a recommended standard salvage therapy is currently not available.
The multimodal metronomic approach combining molecular targeted drugs (rapamycin and dasatinib) with conventional chemotherapy (irinotecan and temozolomide) will be investigated in a randomized fashion as new treatment strategy for patients with rNB. The intention is to assess the therapeutic benefit of molecular targeted drugs for the treatment of rNB.
The combination of irinotecan and temozolomide showed activity in the treatment of several solid organ tumors, brain tumors and neuroblastoma. In one study rNB patients received a median of 5 courses of 5 days irinotecan and temozolomide every 3 to 4 weeks with a cumulative dose of 35% lower than in the RIST design. 33% had disease regression with 8% CR or PR. A phase II study in rNB also using irinotecan and temozolomide with a substantially lower intensity showed a response rate of 15%.
The combination of a mTOR inhibitor with a multi-kinase inhibitor demonstrated in preclinical studies a synergistic effect on cell cycle arrest, apoptosis and sensitization for radio- and chemotherapy. It is assumed that this combination of molecular targeted drugs with a tolerable conventional chemotherapy consisting of irinotecan and temozolomide can substantially improve the outcome of this patient population. A group of 20 rNB patients treated with the RIST therapy approach in a compassionate use setting showed an overall survival of 55% at a median of 80 weeks with a tolerable adverse event profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irinotecan, Temozolomide | Active comparator | Drug: Temozolomide, Drug: IrinotecanPatients randomized to the control arm receive irinotecan (I) and temozolomide (T) alone. |
| Rapamycin, Dasatinib, Temozolomide, Irinotecan | Experimental | Drug: Dasatinib, Drug: Rapamycin, Drug: Irinotecan, Drug: TemozolomidePatients with rNB receive on the study arm the experimental combination of rapamycin (R)- mTOR Inhibitor, dasatinib (D)- protein kinase inhibitor irinotecan (I)- cytostatic topoisomerase-I-inhibitor and temozolomide (T)- Antineoplastic agent |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- Pregnancy, nursing
- Patients who suffered from a thrombotic event and need anticoagulation (i.e. coumadin derivatives or low molecular weight heparin derivatives, LMWH)
- Patients with cardiac arrhythmias especially prolonged QT
- Patients with chronic inflammatory bowel diseases and/or bowel obstruction
- Patients with bilirubin serum levels 1,5 fold above the upper normal limit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasatinibAlso: Sprycel®Pharmacotherapeutic Group: protein kinase inhibitor ATC-Code: L01XE06 Excipients: Tablet core: Lactose monohydrate, Cellulose, microcrystalline, Croscarmellose sodium, Hydroxypropyl cellulose, Magnesium stearate. Film-coating: Hypromellose, Titanium dioxide, Macrogol 400 Formulation: film coated tablet Route of Administration: orally. Patients should be instructed to swallow the tablets as a whole and not to split, chew, or crush them. | Drug | Rapamycin, Dasatinib, Temozolomide, Irinotecan |
| RapamycinAlso: Rapamune®Pharmacotherapeutic Group: Immunosuppressive agents - mTOR Inhibitors ATC-Code: L04A A10 Excipients: Polysorbat 80, Phosal 50 PG ((3-sn-Phosphatidyl)cholin from Soy beans, Propylenglycol, lipid acid mono- and -diglyzeride from Soy oil, Ethanol (1,5% bis 2,5%), Soy liid acid and Palmitoyl ascorbic acid) Formulation: Oral solution Route of Administration:orally | Drug | Rapamycin, Dasatinib, Temozolomide, Irinotecan |
| IrinotecanAlso: Irinomedac®Pharmacotherapeutic Group: cytostatic topoisomerase-I-inhibitor ATC-Code: L01XX19 Excipients: Sorbitol (E420), lactic acid, sodium hydroxid (to adjust the pH to 3.5), water for injection Formulation: concentrate for solution for infusion Route of Administration: intravenously | Drug | Rapamycin, Dasatinib, Temozolomide, Irinotecan |
| TemozolomideAlso: Temomedac®Pharmacotherapeutic Group: Antineoplastic agents - Other alkylating agents, ATC-Code: L01A X03 Excipients: Capsule content: Anhydrous lactose, Sodium starch glycolate Type A, Colloida anhydrous silica, Tartaric acid, Stearic acid. Capsule shell: Gelatine, Titanium dioxide (E171). Printing ink: Shellac Propylene glycol, Titanium dioxide (E171), Sunset yellow FCF Aluminium Lake (E110) Formulation: capsule, hard Route of Administration: orally; Temomedac hard capsules should be administered in the fasting state. The capsules must be swallowed whole with a glass of water and must not be opened or chewed | Drug | Irinotecan, Temozolomide |
| IrinotecanAlso: Irinomedac®Pharmacotherapeutic Group: cytostatic topoisomerase-I-inhibitor ATC-Code: L01XX19 Excipients: Sorbitol (E420), lactic acid, sodium hydroxid (to adjust the pH to 3.5), water for injection Formulation: concentrate for solution for infusion Route of Administration: intravenously | Drug | Irinotecan, Temozolomide |
| TemozolomideAlso: Temomedac®Pharmacotherapeutic Group: Antineoplastic agents - Other alkylating agents, ATC-Code: L01A X03 Excipients: Capsule content: Anhydrous lactose, Sodium starch glycolate Type A, Colloida anhydrous silica, Tartaric acid, Stearic acid. Capsule shell: Gelatine, Titanium dioxide (E171). Printing ink: Shellac Propylene glycol, Titanium dioxide (E171), Sunset yellow FCF Aluminium Lake (E110) Formulation: capsule, hard Route of Administration: orally; Temomedac hard capsules should be administered in the fasting state. The capsules must be swallowed whole with a glass of water and must not be opened or chewed | Drug | Rapamycin, Dasatinib, Temozolomide, Irinotecan |
Primary outcome
The primary endpoint is progression-free survival (PFS)
Time frame: Time interval from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks
The primary objective of this trial is the evaluation of progression-free survival of rNB in children, adolescents and young adults, comparing a multimodal treatment regimen consisting of temozolomide (T), irinotecan (I), rapamycin (R) and dasatinib (S) against irinotecan (I) and temozolomide (T) (I/T) alone
8 secondary outcomes
Overall survival (OS)
Time frame: Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Response to the investigational treatment after 4 and 8 courses of I/T and 1-year-follow-up in the RIST treatment arm
Time frame: Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Duration until adequate response to this treatment regimen
Time frame: Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Assessment of quality of life (Lansky and Karnofsky Scores)
Time frame: • Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Toxicity of this combination of drugs in children, adolescents and young adults with rNB
Time frame: From the first course of the investigational treatment up to the end of the trial assessed to 52 weeks.
Safety and tolerability of the investigational treatment
Time frame: Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Assessment of the prognostic relevance of International Neuroblastoma Risk Group (INRG) classification system on the event free survival
Time frame: Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Prognostic relevance of defined factors on the event free survival in this patient population (i.e. response assessment of HVA, VMA, NSE)
Time frame: Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Derived from this study: PubMed 38936379Corbacioglu S, Lode H, Ellinger S, Zeman F, Suttorp M, Escherich G, Bochennek K, Gruhn B, Lang P, Rohde M, Debatin KM, Steinbach D, Beilken A, Ladenstein R, Spachtholz R, Heiss P, Hellwig D, Troger A, Koller M, Menhart K, Riemenschneider MJ, Zoubaa S, Kietz S, Jakob M, Sommer G, Heise T, Hundsdorfer P, Kuhnle I, Dilloo D, Schonberger S, Schwabe G, von Luettichau I, Graf N, Schlegel PG, Fruhwald M, Jorch N, Paulussen M, Schneider DT, Metzler M, Leipold A, Nathrath M, Imschweiler T, Christiansen H, Schmid I, Crazzolara R, Niktoreh N, Cario G, Faber J, Demmert M, Babor F, Frohlich B, Bielack S, Bernig T, Greil J, Eggert A, Simon T, Foell J. Irinotecan and temozolomide in combination with dasatinib and rapamycin versus irinotecan and temozolomide for patients with relapsed or refractory neuroblastoma (RIST-rNB-2011): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet Oncol. 2024 Jul;25(7):922-932. doi: 10.1016/S1470-2045(24)00202-X.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selim Corbacioglu, MD principal investigator
University of Regensburg, Department of Pediatric Hematology and Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib, Rapamycin and Irinotecan in people with Neuroblastoma Recurrent, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is progression-free survival (PFS) (time frame: Time interval from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01467986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.