The IVADo regimen for children with metastatic soft tissue sarcoma

Objectives:
To evaluate the feasibility of an intensified induction regimen (IVADo), which combines doxorubicin, with the well established ifosfamide, vincristine and actinomycin D (IVA) regimen.

Conclusions from the authors:
The intensive IVADo regimen was effective against pediatric STS with acceptable toxicity. This combination will be investigated in high-risk patients with rhabdomyosarcoma in a randomized trial launched by the European pediatric Soft tissue sarcoma Study Group.
(c) 2005 American Cancer Society.

Official Title

The IVADo regimen- a pilot study with ifosfamide, vincristine, actinomycin D, and doxorubicin in children with metastatic soft tissue sarcoma: a pilot study of behalf of the European pediatric Soft tissue sarcoma Study Group

Conditions

Study Type

Pilot study in preparation for a randomized European trial.

Study Design

Metastatic soft tissue sarcoma (STS): rhabdomyosarcoma (19), peripheral neuroectodermal tumor (5), others (5).IVADoIfosfamide 3000 mg/m2 i.v. (3h inf.) d1+2 with mesnaVincristine 1.5 mg/m2 (max 2 mg) i.v. (bolus) d1Dactinomycin 1.5 mg/m2 (max 2 mg) i.v. (bolus) d1Doxorubicin 30 mg/m2 i.v. (6h inf.) d1+2To be repeated every 3 weeks (3-4 cycles)Induction chemotherapy followed in responding patients by 1 cycle of cyclophosphamide and etoposide for peripheral blood stem cell (PBSC) mobilization, then sequential high-dose therapy (thiotepa-melphalan / cyclophosphamide-thiotepa / melphalan) with PBSC rescue.Radiotherapy and / or surgery for local control when feasible.VACVincristine / Dactinomycin / Cyclophosphamide6 cycles Efficacy: CR + PR: 5 + 17 (76%)

Further Details

Tolerability: % of cycles with NCI Common Toxicity grade 3-4:Neutropenia – 67 (gr 4) Anemia – 40 (gr 4) Thrombocytopenia – 20 (gr 4)Infection / febrile neutropenia 2 (gr 3) ;3 (gr 4)Skin – 1 (gr 3)Hepatic – 1 (gr 3)Mucositis – 4 (gr 3); 2 (gr 4)Renal – 1 (gr 3); 1 (gr 4)Peripheral neurotoxicity – 7 (gr 3)Central neurotoxicity – 2 (gr 4)Constipation – 7 (gr 3); 3 (gr 4)

Study Start

Eligibility & Criteria

Newly diagnosed and histologically confirmed STS, age ≤ 21 years; no prior therapy.

Total Enrolment

33, 29 evaluable

Contact Details

Bisogno,G.; Ferrari,A.; Bergeron,C.; Scagnellato,A.; Prete,A.; Alaggio,R.; Casanova,M.; D’Angelo,P.; Di Cataldo,A.; Carli,M.11 centers belonging to the “Associazione Italiano di Ematologia e Oncologica Pediatrica” (AIEOP)Cancer 103 (2005): 1719-1724