Clinical trial · Interventional
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation with treated peripheral stem cells following combination chemotherapy to see how well it works compared to peripheral stem cell transplantation with untreated peripheral stem cells following combination chemotherapy in treating patients with neuroblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (15)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (unpurged PBSC collection)
- description
- Induction-3 wks (cyclophosphamide day 0\&1, doxorubicin hydrochloride \& vincristine sulfate day 0-2 \& filgrastim(G-CSF) day 3 crs 1,2,4 \& 6.) Crs 3 \& 5 (etoposide day 0-2, cisplatin day 0-3, G-CSF day 4). Pts undergo unpurged PBSC collection until the target cell count is reached. Surgical resection of the tumor after crs 5 of induct. CR, VGPR, PR after induct receive consolidation (melphalan day -7 to -5, carboplatin \& etoposide day -7 to -4. purged peripheral blood stem cell transplantation infusion day 0, G-CSF 4 hrs post transplant. Day 66, isotretinoin 2x day/14 days. Isotretinoin every 4 wks 6 crs. After consol (28 days from stem cell infusion), radiation therapy 1x day/7 days. Not undergoing autologous bone marrow transplantation receive maintenance(cyclophosphamide 30 mins, topotecan hydrochloride days 0-4, G-CSF day 5). Maint every 3 wks/3 crs. Radiation therapy and Isotretinoin 2x day/14 days then every 4 wks for 6 crs.
- interventionNames
- Biological: filgrastim
- Drug: carboplatin
- Drug: cisplatin
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: etoposide
- Drug: isotretinoin
- Drug: melphalan
- Drug: topotecan hydrochloride
- Drug: vincristine sulfate
- Procedure: autologous bone marrow transplantation
- Procedure: bone marrow ablation with stem cell support
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed newly diagnosed neuroblastoma OR ganglioneuroblastoma, and/or evidence of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, meeting 1 of the following criteria:
* Age greater than 18 months with stage IV disease, regardless of biologic factors
* Age 12-18 months with stage IV disease meeting one of the following criteria:
* Any unfavorable biologic feature (e.g., MYCN amplification, unfavorable pathology, and/or DNA index = 1)
* Any biologic feature that is indeterminate, unsatisfactory, or unknown
* At least 1 year old with the following:
* Stage IIa/IIb with MYCN amplification (\> 10) AND unfavorable pathology
* Stage III with MYCN amplification (\> 10) OR unfavorable pathology
* Stage I, II, or IVS with disease progression to stage IV without interval chemotherapy
* No more than 3 weeks since progression
* Must have been enrolled on protocol CCG-B973, COG-ANBL00B1, or POG-9047
* Less than 1 year old with the following:
* Stage III, IV, or IVS disease with MYCN amplification (\> 10)
* Registration on protocol COG-ANBL00B1 required within 14 days of diagnosis
PATIENT CHARACTERISTICS:
Age:
* See Disease Characteristics
* 30 and under at time of diagnosis
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Inadequate hematopoiesis secondary to bone marrow involvement with \> 10% tumor infiltration allowed
Hepatic:
* Bilirubin ≤ 1.5 mg/dL
* ALT ≤ 300 units/L
Renal:
* Creatinine ≤ 1.5 mg/dL
* Creatinine clearance or glomerular filtration rate ≥ 60 mL/min
Cardiovascular:
* ECG normal
* Ejection fraction ≥ 55% by echocardiogram or MUGA OR
* Fractional shortening ≥ 28% by echocardiogram
Other:
* Able to tolerate peripheral blood stem cell collection
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for at least 1 month prior to, during, and for 1 month after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* No more than 1 prior course of chemotherapy on the Intergroup low/intermediate risk neuroblastoma study (P9641, A3961)
Endocrine therapy:
* Not specified
Radiotherapy:
* Prior localized emergency radiotherapy to sites of life-threatening or function-threatening disease allowed
Surgery:
* Not specified
Other
* No other prior systemic therapyReferences
Publications (8)
- BACKGROUNDDubois SG, Geier E, Batra V, Yee SW, Neuhaus J, Segal M, Martinez D, Pawel B, Yanik G, Naranjo A, London WB, Kreissman S, Baker D, Attiyeh E, Hogarty MD, Maris JM, Giacomini K, Matthay KK. Evaluation of Norepinephrine Transporter Expression and Metaiodobenzylguanidine Avidity in Neuroblastoma: A Report from the Children's Oncology Group. Int J Mol Imaging. 2012;2012:250834. doi: 10.1155/2012/250834. Epub 2012 Sep 25. PMID 23050139
- BACKGROUNDCantos MF, Gerstle JT, Irwin MS, Pappo A, Farley S, Cheang T, Kim PC. Surgical challenges associated with intensive treatment protocols for high-risk neuroblastoma. J Pediatr Surg. 2006 May;41(5):960-5. doi: 10.1016/j.jpedsurg.2006.01.059. PMID 16677893
- BACKGROUNDKushner BH, Budnick A, Kramer K, Modak S, Cheung NK. Ototoxicity from high-dose use of platinum compounds in patients with neuroblastoma. Cancer. 2006 Jul 15;107(2):417-22. doi: 10.1002/cncr.22004. PMID 16779793
- RESULTLandier W, Knight K, Wong FL, Lee J, Thomas O, Kim H, Kreissman SG, Schmidt ML, Chen L, London WB, Gurney JG, Bhatia S. Ototoxicity in children with high-risk neuroblastoma: prevalence, risk factors, and concordance of grading scales--a report from the Children's Oncology Group. J Clin Oncol. 2014 Feb 20;32(6):527-34. doi: 10.1200/JCO.2013.51.2038. Epub 2014 Jan 13. PMID 24419114
- RESULTNaranjo A, Parisi MT, Shulkin BL, London WB, Matthay KK, Kreissman SG, Yanik GA. Comparison of (1)(2)(3)I-metaiodobenzylguanidine (MIBG) and (1)(3)(1)I-MIBG semi-quantitative scores in predicting survival in patients with stage 4 neuroblastoma: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2011 Jul 1;56(7):1041-5. doi: 10.1002/pbc.22991. Epub 2011 Feb 15. PMID 21328522
- RESULTYanik GA, Parisi MT, Naranjo A, et al.: MIBG scoring as a prognostic indicator in patients with stage IV neuroblastoma: A COG study. [Abstract] J Clin Oncol 28 (Suppl 15): A-9516, 2010.
- Kreissman SG, Villablanca JG, Diller L, et al.: Response and toxicity to a dose-intensive multi-agent chemotherapy induction regimen for high risk neuroblastoma (HR-NB): a Children's Oncology Group (COG A3973) study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9505, 527s, 2007.