Phase II Study of the Association of Iodobenzylguanidine Meta-I131 (I131 MIBG) and Topotecan in the Treatment of Refractory or Relapsed Metastatic Neuroblastoma
1 Year
20 Years
Both
Neuroblastoma
Trial Information
Phase II Study of the Association of Iodobenzylguanidine Meta-I131 (I131 MIBG) and Topotecan in the Treatment of Refractory or Relapsed Metastatic Neuroblastoma
OBJECTIVES:
Primary
- Determine the antitumor activity of iodobenzylguanidine meta-I131 (^131I-MIBG) and
topotecan in young patients with refractory or relapsed metastatic neuroblastoma.
Secondary
- Determine the hematological and extra-hematological toxicities of this regimen.
OUTLINE: This is a multicenter study.
During the 21 days before treatment begins, autologous peripheral blood stem cells (PBSC)
are collected.
Patients receive topotecan hydrochloride IV over 30 minutes daily on days 1-5 and
iodobenzylguanidine meta-^131I IV over 2 hours on day 1. Treatment repeats every 21 days for
2 courses. Patients also undergo total-body irradiation.
On day 10 of the second course, autologous PBSC are reinfused.
After completion of study therapy, patients are followed at 6 and 12 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Safety Issue:
No
Principal Investigator
Anne-Sophie Defachelles
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Oscar Lambret
Authority:
Unspecified
Study ID:
CDR0000633586
NCT ID:
NCT00960739
Start Date:
January 2009
Completion Date:
Related Keywords:
- Neuroblastoma
- disseminated neuroblastoma
- localized unresectable neuroblastoma
- recurrent neuroblastoma
- stage 4S neuroblastoma
- Neuroblastoma
Name | Location |
|---|
