Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Isotretinoin; Liposomal doxorubicin; Melphalan; Sargramostim; Thiotepa; Vincristine

Criteria

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 neuroblastoma