Clinical trial · Interventional
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma
A Pilot Study Of Tandem High Dose Chemotherapy With Stem Cell Rescue Following Induction Therapy In Children With High Risk Neuroblastoma
NCT00017368CI-TRIAL-00013747completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 more than one drug may kill more tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have newly diagnosed 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 (16)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 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 |
| etoposide phosphate | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All Patients
- interventionNames
- Biological: filgrastim
- Biological: sargramostim
- Drug: carboplatin
- Drug: cisplatin
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: etoposide
- Drug: etoposide phosphate
- Drug: ifosfamide
- Drug: isotretinoin
- Drug: melphalan
- Drug: thiotepa
- Drug: vincristine sulfate
- Procedure: conventional surgery
- Procedure: peripheral blood stem cell transplantation
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Transplant-related mortality
- description
- The endpoint used for early stopping rule 9.51 will be transplant-related mortality (TRM). A TRM is defined as any death occurring within 30 days after either the first or second HDC/SCR. The acceptable TRM rate is 7.5%. This rate is based on TRM rates previously observed in the prior CCG study 594, CCG study 3891, and POG study 9640 of 7%, 6%, and 0%, respectively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Newly diagnosed high-risk neuroblastoma
* Histologically proven AND/OR
* Bone marrow specimen showing clumps of tumor cells accompanied by elevated urinary catecholamines
* Age 1-30:
* Must meet one of the following INSS staging criteria:
* Stage IV regardless of biologic factors
* Stage IIa/IIb with MYCN oncogene amplification (greater than 10) and unfavorable pathology
* Stage III with MYCN oncogene amplification (greater than 10) or unfavorable pathology
* Initially stage I, II, or IVS, that has progressed without interval chemotherapy
* Under age 1:
* INSS stage III, IV, or IVS with MYCN amplification (greater than 10)
* Must enter neuroblastoma biology study COG-ANBL00B1 within 2 weeks of diagnosis and before entry on this study
PATIENT CHARACTERISTICS:
Age:
* 30 and under at original diagnosis
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* No more than 1 prior course of chemotherapy on the intergroup low- or intermediate-risk neuroblastoma studies prior to determination of MYCN status and Shimada histology
Endocrine therapy:
* Not specified
Radiotherapy:
* Prior emergent radiotherapy to sites of function- or life-threatening neuroblastoma allowed
Surgery:
* Not specified
Other:
* No other prior systemic therapy for neuroblastomaReferences
Publications (5)
- BACKGROUNDMarcus KJ, Shamberger R, Litman H, von Allmen D, Grupp SA, Nancarrow CM, Goldwein J, Grier HE, Diller L. Primary tumor control in patients with stage 3/4 unfavorable neuroblastoma treated with tandem double autologous stem cell transplants. J Pediatr Hematol Oncol. 2003 Dec;25(12):934-40. doi: 10.1097/00043426-200312000-00005. PMID 14663275
- BACKGROUNDKletzel M, Katzenstein HM, Haut PR, Yu AL, Morgan E, Reynolds M, Geissler G, Marymount MH, Liu D, Kalapurakal JA, Shore RM, Bardo DM, Schmoldt J, Rademaker AW, Cohn SL. Treatment of high-risk neuroblastoma with triple-tandem high-dose therapy and stem-cell rescue: results of the Chicago Pilot II Study. J Clin Oncol. 2002 May 1;20(9):2284-92. doi: 10.1200/JCO.2002.06.060. PMID 11980999
- BACKGROUNDDonovan J, Temel J, Zuckerman A, Gribben J, Fang J, Pierson G, Ross A, Diller L, Grupp SA. CD34 selection as a stem cell purging strategy for neuroblastoma: preclinical and clinical studies. Med Pediatr Oncol. 2000 Dec;35(6):677-82. doi: 10.1002/1096-911x(20001201)35:63.0.co;2-h. PMID 11107145
- BACKGROUNDGrupp SA, Stern JW, Bunin N, Nancarrow C, Adams R, Gorlin JB, Griffin G, Diller L. Rapid-sequence tandem transplant for children with high-risk neuroblastoma. Med Pediatr Oncol. 2000 Dec;35(6):696-700. doi: 10.1002/1096-911x(20001201)35:63.0.co;2-0. PMID 11107149
- BACKGROUNDGrupp SA, Stern JW, Bunin N, Nancarrow C, Ross AA, Mogul M, Adams R, Grier HE, Gorlin JB, Shamberger R, Marcus K, Neuberg D, Weinstein HJ, Diller L. Tandem high-dose therapy in rapid sequence for children with high-risk neuroblastoma. J Clin Oncol. 2000 Jul;18(13):2567-75. doi: 10.1200/JCO.2000.18.13.2567. PMID 10893288