Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma

• Status: Completed
• Trial end date: 1969-12-31
• 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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation with treated peripheral stem cells following combination chemotherapy to see how well it works compared to peripheral stem cell transplantation with untreated peripheral stem cells following combination chemotherapy in treating patients with neuroblastoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed neuroblastoma OR ganglioneuroblastoma, and/or evidence of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, meeting 1 of the following criteria:

• Age greater than 18 months with stage IV disease, regardless of biologic factors

• Age 12-18 months with stage IV disease meeting one of the following criteria:

• Any unfavorable biologic feature (e.g., MYCN amplification, unfavorable pathology, and/or DNA index = 1)

• Any biologic feature that is indeterminate, unsatisfactory, or unknown

• At least 1 year old with the following:

• Stage IIa/IIb with MYCN amplification (> 10) AND unfavorable pathology

• Stage III with MYCN amplification (> 10) OR unfavorable pathology

• Stage I, II, or IVS with disease progression to stage IV without interval chemotherapy

• No more than 3 weeks since progression

• Must have been enrolled on protocol CCG-B973, COG-ANBL00B1, or POG-9047

• Less than 1 year old with the following:

• Stage III, IV, or IVS disease with MYCN amplification (> 10)

• Registration on protocol COG-ANBL00B1 required within 14 days of diagnosis

PATIENT CHARACTERISTICS:

Age:

• See Disease Characteristics

• 30 and under at time of diagnosis

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count ≥ 1,000/mm^3

• Platelet count ≥ 100,000/mm^3

• Inadequate hematopoiesis secondary to bone marrow involvement with > 10% tumor infiltration allowed

Hepatic:

• Bilirubin ≤ 1.5 mg/dL

• ALT ≤ 300 units/L

Renal:

• Creatinine ≤ 1.5 mg/dL

• Creatinine clearance or glomerular filtration rate ≥ 60 mL/min

Cardiovascular:

• ECG normal

• Ejection fraction ≥ 55% by echocardiogram or MUGA OR

• Fractional shortening ≥ 28% by echocardiogram

Other:

• Able to tolerate peripheral blood stem cell collection

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception for at least 1 month prior to, during, and for 1 month after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No more than 1 prior course of chemotherapy on the Intergroup low/intermediate risk neuroblastoma study (P9641, A3961)

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