Topotecan, Vincristine, and Doxorubicin in Treating Young Patients With Refractory Stage 4 Neuroblastoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, vincristine, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving topotecan together with vincristine and doxorubicin works in treating young patients with refractory stage 4 neuroblastoma.

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

Details

• Lead Sponsor: Children's Cancer and Leukaemia Group
• Treatments: Doxorubicin; Liposomal doxorubicin; Topotecan; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of stage 4 neuroblastoma

• Failed to achieve adequate metastatic partial response after first-line therapy while enrolled on protocol SIOP-EUROPE-HR-NBL-1

PATIENT CHARACTERISTICS:

• Neutrophil count > 1,000/mm³

• Platelet count ≥ 100,000/mm³

• Creatinine ≤ 1.36 mg/dL

• Bilirubin ≤ 2.92 mg/dL

• AST and ALT < 2.5 times upper limit of normal

• Glomerular filtration rate ≥ 60 mL/min

• Normal cardiac function on echocardiography

• No severe organ dysfunction

• No active hepatitis C or hepatitis B virus positivity

• No HIV infection

PRIOR CONCURRENT THERAPY:

• No anti-tumor chemotherapy within the past 10 days

• No radiotherapy within the past 30 days

• No other investigational drugs within the past 30 days

• No prior doxorubicin hydrochloride