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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neuroblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topotecan / 131-iodine MIBG association

* The topotecan hydrochloride is administered intravenously over five days to dose of 0.7 mg/ m²/day from day 1 to day 5 (first cycle), then from day 21 to day 25 (second cycle). \*
* Iobenguane I 131: 444 MBq / kg of 131-iodine MIBG is administered on day 1 with activity up to 11,100 MBq per injection. \*
* A dosimetry is performed during hospitalization.
* A second dose of 131-iodine MIBG (maximum 11 100 MBq) is administered to D21 so as to obtain a total body irradiation of 4 Gy. \*
* Autologous hematopoietic stem cell transplantation : Hematopoietic stem cells are reinjected 10 days after the second injection of 131-iodine MIBG.

* If the dose of total-body irradiation of 4 Gy is reached during the first cycle, the second cycle is canceled.

Group Type EXPERIMENTAL

Topotecan hydrochloride

Intervention Type DRUG

The topotecan hydrochloride is administered intravenously over five days to dose of 0.7 mg/ m²/day from day 1 to day 5 (first cycle), then from day 21 to day 25 (second cycle)

Autologous hematopoietic stem cell transplantation

Intervention Type PROCEDURE

Hematopoietic stem cells are reinjected 10 days after the second injection of 131-iodine MIBG

iobenguane I 131

Intervention Type RADIATION

444 MBq / kg of 131-iodine MIBG is administered on day 1 with activity

total-body irradiation

Intervention Type RADIATION

the dose of total-body irradiation of 4 Gy is reached during the first cycle, the second cycle is canceled (131-iodine MIBG and Topotecan)

Interventions

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Topotecan hydrochloride

The topotecan hydrochloride is administered intravenously over five days to dose of 0.7 mg/ m²/day from day 1 to day 5 (first cycle), then from day 21 to day 25 (second cycle)

Intervention Type DRUG

Autologous hematopoietic stem cell transplantation

Hematopoietic stem cells are reinjected 10 days after the second injection of 131-iodine MIBG

Intervention Type PROCEDURE

iobenguane I 131

444 MBq / kg of 131-iodine MIBG is administered on day 1 with activity

Intervention Type RADIATION

total-body irradiation

the dose of total-body irradiation of 4 Gy is reached during the first cycle, the second cycle is canceled (131-iodine MIBG and Topotecan)

Intervention Type RADIATION

Other Intervention Names

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Topotecan hematopoietic stem cell transplantation

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No