A Pilot Study Of Tandem High Dose Chemotherapy With Stem Cell Rescue Following Induction Therapy In Children With High Risk Neuroblastoma

NCT00017368 Phase 2 COMPLETED

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.

Details

Lead sponsor	Children's Oncology Group
Phase	Phase 2
Status	COMPLETED
Enrolment	42
Start date	2001-04
Completion	2012-01

Conditions

• Neuroblastoma

Interventions

• filgrastim
• sargramostim
• carboplatin
• cisplatin
• cyclophosphamide
• doxorubicin hydrochloride
• etoposide
• etoposide phosphate
• ifosfamide
• isotretinoin

Primary outcomes

• Transplant-related mortality
  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.

Countries

United States, Australia