Neoplasms

All Conditions

Rare Diseases

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Dermatologic Agents

Anti-Infective Agents

Etoposide

Cyclophosphamide

Carboplatin

Doxorubicin

Liposomal doxorubicin

Topotecan

Vincristine

Melphalan

Cisplatin

Ifosfamide

Etoposide phosphate

Isotretinoin

Vindesine

Tretinoin

Isophosphamide mustard

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Topoisomerase I Inhibitors

Tubulin Modulators

Antimitotic Agents

Drug: Cycles N8, N5, and N6 Drug: topotecan, cyclophosphamide, and etoposide (N8 cycle) followed by Drug: cisplatin, etoposide, and vindesine (N5 cycle) and Drug: vincristine, dacarbacine, ifosfamide, and doxorubicine (N6 cycle) followed by myeloablative chemotherapy with autologous stem cell transplantation (melphalan, carboplatin, etoposide) and by 9 x retinoic acid cycles (6 months, 3 months break, 3 months)

Drug: Cycles N5 and N6 Drug: cisplatin, etoposide, and vindesine (N5 cycle) and Drug: vincristine, dacarbacine, ifosfamide, and doxorubicine (N6 cycle) followed by myeloablative chemotherapy with autologous stem cell transplantation (melphalan, carboplatin, etoposide) and by 9 x retinoic acid cycles (6 months, 3 months break, 3 months)

two chemotherapy cycles N8 followed by standard arm therapy

Cycles N8, N5 and N6

Standard arm six chemotherapy cycles (3xN5 and 3x N6) followed by myeloablative therapy with stem cell support and isotretinoin

Cycles N5 and N6

Frank Berthold, Prof.

Improvement of event free survival of high-risk neuroblastoma patients by introduction of two additional topotecan containing chemotherapy cycles into the multimodal standard treatment (induction chemotherapy, myeloablative therapy, radiation, surgery as indicated, and consolidation therapy).

Experimental intervention (6 weeks + duration of the control intervention):

2 x N8 cycle (topotecan, cyclophosphamide, and etoposide) followed by standard arm treatment (i.e., control intervention)

Control intervention (total duration 70-76 weeks):

3 x N5 cycle (cisplatin, etoposide, and vindesine) 3 x N6 cycle (vincristine, dacarbacine, ifosfamide, and doxorubicine), myeloablative chemotherapy with autologous stem cell transplantation (melphalan, carboplatin, etoposide) 9 x retinoic acid cycles (6 months, 3 months break, 3 months) supportive care (PCP/fungal prophylaxis, transfusions, antibiotics, G-CSF)

Randomized, multi-center, non-blinded, prospective, controlled trial

Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients

Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-risk Neuroblastoma

days from diagnosis to Event or last follow-up

days from diagnosis to death or last follow-up

remission status (INRG) measured after 2 chemotherapy cycles

remission status (INRG) measured before stem cell transplant

University of Cologne

Prof. Dr.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients	NCT03042429	Neuroblastoma	Cycles N8, N5 a... Cycles N5 and N...	6 Months - 21 Years	University of Cologne
Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients	NCT03042429	Neuroblastoma	Cycles N8, N5 a... Cycles N5 and N...	6 Months - 21 Years	University of Cologne

Spots Global Cancer Trial Database for cycles n5 and n6