Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma
NCT ID: NCT00808899
Last Updated: 2017-05-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2008-12-31
2009-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Therapy for Children With Neuroblastoma
NCT00135135
Therapy for Children With Advanced Stage High Risk Neuroblastoma
NCT00186849
Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma
NCT00567567
Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
NCT00004068
Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma
NCT00410631
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Following initial treatment children will undergo alternating courses of induction chemotherapy with cyclophosphamide, doxorubicin, etoposide, topotecan, and cisplatin (Block 2). The first cohort of 17 patients will receive Block 2 with temsirolimus (50mg/m2) for all three courses, weekly 2 times. If this is not tolerated subsequent patients will receive Block 2 chemotherapy with reduced dosages of temsirolimus (25mg/m2).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Fixed doses of IV temsirolimus concomitantly with two courses of fixed dosages of irinotecan, 2 days off, repeated daily 5 times.If initial dosages are not tolerable, subsequent patients will be given a reduced dosage of temsirolimus with irinotecan.If this dosage combination is not tolerable,irinotecan dosage will be decreased.If this dosage combination is not tolerable.Further enrollment to initial six week treatment will be terminated.Second course of irinotecan will begin on day 22, response will be determined after six weeks. Resection of primary tumor will be attempted after initial therapy.Following initial treatment children will undergo alternating courses of induction chemotherapy with cyclophosphamide,doxorubicin,etoposide,topotecan, and cisplatin.First cohort of 17 patients will receive Block 2 with temsirolimus for all three courses, weekly 2 times.If this is not tolerated subsequent patients will receive Block 2 chemotherapy with reduced dosages of temsirolimus.
Temsirolimus
Temsirolimus
Irinotecan
Irinotecan
Surgical Resection of Primary Tumor
Surgical Resection of Primary Tumor
Cyclophosphamide
Cyclophosphamide
Doxorubicin
Doxorubicin
Etoposide
Etoposide
Cisplatin
Cisplatin
Topotecan
Topotecan
PBSC
Peripheral Blood Stem Cell Harvest
Radiation Therapy
Radiation Therapy
13-cis-retinoic acid
13-cis-retinoic acid
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Temsirolimus
Temsirolimus
Irinotecan
Irinotecan
Surgical Resection of Primary Tumor
Surgical Resection of Primary Tumor
Cyclophosphamide
Cyclophosphamide
Doxorubicin
Doxorubicin
Etoposide
Etoposide
Cisplatin
Cisplatin
Topotecan
Topotecan
PBSC
Peripheral Blood Stem Cell Harvest
Radiation Therapy
Radiation Therapy
13-cis-retinoic acid
13-cis-retinoic acid
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Children \< 1 yo with International Neuroblastoma Staging System (INSS) stage 2a, 2b, 3, 4 or 4S disease and MYCN amplification (\>10 copies, or greater than four-fold increase in MYCN signal as compared to reference signal)
* INSS 2a or 2b disease and MYCN amplification, regardless of age or additional biologic features
* INSS stage 3 and:
1. MYCN amplification (\>10 copies, or greater than four-fold increase in MYCN signal as compared to reference signal, regardless of age or additional biologic features
2. Age \> 18 mo (\> 547 days) with unfavorable pathology, regardless of MYCN status
* INSS stage 4 and:
1. MYCN amplification, regardless of age or additional biologic features
2. Age \> 18 months (\> 547 days) regardless of biologic features
3. Age 12 - 18 months (365 - 547 days) with any of the following three unfavorable biologic features (MYCN amplification, unfavorable pathology and/or DNA index =1) or any biologic feature that is indeterminant/unknown
* Children less than or equal to 365 days initially diagnosed with: INSS stage 1, 2, 4S who progressed to a stage 4 without interval chemotherapy.
* Histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines.
* Adequate renal and hepatic function (serum creatinine \<3 x upper limit of normal for age, (AST) aspartate aminotransferase \< 3 x upper limit of normal).
* No prior therapy, unless an emergency situation requires local tumor treatment (discuss with PI)
* Written, informed consent according to institutional guidelines
Exclusion Criteria
* Pregnant or breast feeding (women of child-bearing potential).
* Children with INSS 4 disease, age \<12 months with all 3 favorable biologic features (non-amplified MYCN, favorable pathology and DNA index \>1).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
St. Jude Children's Research Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wayne L Furman, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NB2008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.