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NeuroblastomaPhase 2MIITOPNCT00960739

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

A Phase 2 study testing Topotecan hydrochloride, Autologous hematopoietic stem cell transplantation and iobenguane I 131 in people with Neuroblastoma, run by Centre Oscar Lambret at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 year to 20 years
Conditions the study is for
Neuroblastoma
What is being tested?
Topotecan hydrochloride, Autologous hematopoietic stem cell transplantation and iobenguane I 131
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesFrance
Study dates
Nov 2008to Jul 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Léon Bérard

    Lyon, 69373

  • Hôpital des Enfants

    Toulouse, 31059

Other trials in France

About this study

Official title: Phase II Study of the Association of Iodobenzylguanidine Meta-I131 (I131 MIBG) and Topotecan in the Treatment of Refractory or Relapsed Metastatic Neuroblastoma

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.

Read the 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

  • 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
Neuroblastoma
Being tested
Topotecan hydrochloride, Autologous hematopoietic stem cell transplantation, iobenguane I 131, total-body irradiation
Keywords
disseminated neuroblastoma, localized unresectable neuroblastoma, recurrent neuroblastoma, stage 4S neuroblastoma
Medical subject headings
Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Topotecan hydrochlorideDrug

    Also called Topotecan

    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 transplantationProcedure or surgery

    Also called hematopoietic stem cell transplantation

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

  • iobenguane I 131Radiation

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

  • total-body irradiationRadiation

    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)

Study groups in NCT00960739
Study groupRoleWhat they receive
Topotecan / 131-iodine MIBG associationExperimental* 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.
Receives: Drug: Topotecan hydrochloride; Procedure: Autologous hematopoietic stem cell transplantation; Radiation: iobenguane I 131; Radiation: total-body irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Measured: Up to 12 months

Secondary outcomes (1)

  1. Toxicity

    Measured: Up to 30 days after study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionMar 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00960739
Sponsor's protocol ID
MIITOP-0607
Acronym
MIITOP
Status last verified
Aug 2016
First submitted
16 Aug 2009
Last updated
8 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Sevrin F, Kolesnikov-Gauthier H, Cougnenc O, Bogart E, Schleiermacher G, Courbon F, Gambart M, Giraudet AL, Corradini N, Badel JN, Rault E, Oudoux A, Deley MCL, Valteau-Couanet D, Defachelles AS. Phase II study of 131 I-metaiodobenzylguanidine with 5 days of topotecan for refractory or relapsed neuroblastoma: Results of the French study MIITOP. Pediatr Blood Cancer. 2023 Nov;70(11):e30615. doi: 10.1002/pbc.30615. Epub 2023 Aug 13.

    PubMed 37574821

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Topotecan hydrochloride, Autologous hematopoietic stem cell transplantation and iobenguane I 131 in people with Neuroblastoma, run by Centre Oscar Lambret at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00960739, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.

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