Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan and cyclophosphamide, use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects of induction chemotherapy using cyclophosphamide and topotecan in treating patients who are undergoing surgery and autologous stem cell transplantation followed by radiation therapy for newly diagnosed or progressive neuroblastoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Doxorubicin; Etoposide; Isotretinoin; Lenograstim; Liposomal doxorubicin; Melphalan; Topotecan; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed neuroblastoma or ganglioneuroblastoma meeting 1 of the following staging criteria:

• Newly diagnosed disease, at least 1 year of age, and meets criteria for 1 of the following:

• International Neuroblastoma Staging System (INSS) stage 2a/2b with MYCN amplification (greater than 10) AND unfavorable pathology

• INSS stage 3 with MYCN amplification OR unfavorable pathology

• Newly diagnosed INSS stage 4 disease meeting criteria for 1 of the following:

• Over 18 months of age

• Age 12 to 18 months with any unfavorable biologic feature (MYCN amplification, unfavorable pathology, and/or DNA index=1) or any biologic feature that is indeterminant, unsatisfactory, or unknown

• No INSS stage 4 disease and age 12 to 18 months with all 3 favorable biologic features (i.e., nonamplified MYCN, favorable pathology, and DNA index greater than 1)

• Newly diagnosed INSS stage 3, 4, or 4S disease AND under 1 year of age with MYCN amplification

• At least 1 year of age and initially diagnosed with INSS stage 1, 2, or 4S disease that progressed to stage 4 without interval chemotherapy

• Must have been enrolled on COG-ANBL00B1 at initial diagnosis

PATIENT CHARACTERISTICS:

Age

• 30 and under at initial diagnosis

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,000/mm^3*

• Platelet count at least 100,000/mm^3* (transfusion independent)

• Hemoglobin at least 10.0 g/dL* (red blood cell transfusions allowed) NOTE:

*Granulocytopenia, anemia, and/or thrombocytopenia allowed for patients with tumor metastatic to the bone marrow

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• ALT less than 300 IU/L

Renal

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min

Cardiovascular

• ECG normal

• Shortening fraction at least 27% by echocardiogram OR

• Ejection fraction at least 50% by MUGA

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• No more than 1 prior chemotherapy course on the low- or intermediate-risk neuroblastoma studies (COG-P9641, COG-A3961) prior to determination of MYCN amplification and Shimada histology

Endocrine therapy

• Not specified

Radiotherapy

• Prior localized emergency radiotherapy to sites of life-threatening or function-threatening disease allowed

Surgery

• Not specified

Other

• No other prior systemic therapy