Status:
COMPLETED
Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma
Lead Sponsor:
Centre Oscar Lambret
Collaborating Sponsors:
National Cancer Institute, France
Novartis Pharmaceuticals
Conditions:
Neuroblastoma
Eligibility:
All Genders
1-20 years
Phase:
PHASE2
Brief 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,...
Detailed Description
OBJECTIVES: Primary * Determine the antitumor activity of iodobenzylguanidine meta-I131 (\^131I-MIBG) and topotecan in young patients with refractory or relapsed metastatic neuroblastoma. Secondary...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00960739
Start Date
November 1 2008
End Date
July 1 2016
Last Update
August 8 2016
Active Locations (3)
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1
Centre Oscar Lambret
Lille, France, 59020
2
Centre Léon Bérard
Lyon, France, 69373
3
Hôpital des Enfants
Toulouse, France, 31059