Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radioactive drugs, such as iodobenzylguanidine meta-I131, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A stem cell transplant may be able to replace the cells that were destroyed by iodobenzylguanidine meta-i131 and topotecan hydrochloride.

PURPOSE: This phase II trial is studying the side effects of iodobenzylguanidine meta-I131 given together with topotecan hydrochloride and to see how well it works in treating young patients with refractory or relapsed metastatic neuroblastoma.

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

Details

• Lead Sponsor: Centre Oscar Lambret
• Collaborators: National Cancer Institute, France; Novartis Pharmaceuticals
• Treatments: 3-Iodobenzylguanidine; Iodine; Topotecan

Criteria

Inclusion criteria:

• Histologically confirmed neuroblastoma

• Metastatic disease that is recurrent or refractory to induction therapy

• Primary or metastatic tumor target with MIBG fixation (tumor/soft tissue) > 2

• Autologous bone marrow or peripheral blood stem cells must be available

• WHO performance status (PS) 0-1 OR Lansky PS 70-100%

• Life expectancy > 2 months

• ANC ≥ 1,000/mm³

• Platelet count ≥ 100,000/mm³

• Creatinine clearance normal for age

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No prior hypersensitivity to topotecan or its excipients

• No toxicity to other organs ≥ NCI-CTCAE v3.0 grade 2

• No other debilitating disease

• No HIV positivity

• More than 30 days since prior external-beam radiation (6 weeks if cranio-spinal, abdominal, or pulmonary)

• At least 3 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)

• No other contraindicated biologic therapy that cannot be discontinued for ≥ 4 courses during MIBG therapy

Exclusion criteria:

• Pregnancy or breastfeeding women

• HIV positive

• Participation to another phase I,II or III clinical trial

• Other invalidating pathology

• Concomitant treatment interfering with MIBG

• Hypersensibility to Topotecan