Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients

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

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-01

Study Completion Date

2016-12-31

Brief Summary

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Improvement of event free survival of high-risk neuroblastoma patients by introduction of two additional topotecan containing chemotherapy cycles into the multimodal standard treatment (induction chemotherapy, myeloablative therapy, radiation, surgery as indicated, and consolidation therapy).

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Detailed Description

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Experimental intervention (6 weeks + duration of the control intervention):

2 x N8 cycle (topotecan, cyclophosphamide, and etoposide) followed by standard arm treatment (i.e., control intervention)

Control intervention (total duration 70-76 weeks):

3 x N5 cycle (cisplatin, etoposide, and vindesine) 3 x N6 cycle (vincristine, dacarbacine, ifosfamide, and doxorubicine), myeloablative chemotherapy with autologous stem cell transplantation (melphalan, carboplatin, etoposide) 9 x retinoic acid cycles (6 months, 3 months break, 3 months) supportive care (PCP/fungal prophylaxis, transfusions, antibiotics, G-CSF)

Conditions

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Neuroblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Randomized, multi-center, non-blinded, prospective, controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

no masking

Study Groups

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experimental arm

Drug: Cycles N8, N5, and N6 Drug: topotecan, cyclophosphamide, and etoposide (N8 cycle) followed by Drug: cisplatin, etoposide, and vindesine (N5 cycle) and Drug: vincristine, dacarbacine, ifosfamide, and doxorubicine (N6 cycle) followed by myeloablative chemotherapy with autologous stem cell transplantation (melphalan, carboplatin, etoposide) and by 9 x retinoic acid cycles (6 months, 3 months break, 3 months)

Group Type EXPERIMENTAL

Cycles N8, N5 and N6

Intervention Type DRUG

two chemotherapy cycles N8 followed by standard arm therapy

standard arm

Drug: Cycles N5 and N6 Drug: cisplatin, etoposide, and vindesine (N5 cycle) and Drug: vincristine, dacarbacine, ifosfamide, and doxorubicine (N6 cycle) followed by myeloablative chemotherapy with autologous stem cell transplantation (melphalan, carboplatin, etoposide) and by 9 x retinoic acid cycles (6 months, 3 months break, 3 months)

Group Type ACTIVE_COMPARATOR

Cycles N5 and N6

Intervention Type DRUG

Standard arm six chemotherapy cycles (3xN5 and 3x N6) followed by myeloablative therapy with stem cell support and isotretinoin

Interventions

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Cycles N8, N5 and N6

two chemotherapy cycles N8 followed by standard arm therapy

Intervention Type DRUG

Cycles N5 and N6

Standard arm six chemotherapy cycles (3xN5 and 3x N6) followed by myeloablative therapy with stem cell support and isotretinoin

Intervention Type DRUG

Other Intervention Names

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topotecan, cyclophosphamide, etoposide cisplatin, vindesine, ifosfamide, dacarbacine, doxorubicine

Eligibility Criteria

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Inclusion Criteria

* neuroblastoma
* stage 4 neuroblastoma and age ≥1 - 21 years or MYCN amplification and age ≥6 months - 21 years
* informed consent obtained

Exclusion Criteria

* Participation in other trials
* Pregnancy, lactation, or insufficient contraception for girls in childbearing age,
* Any concomitant non-protocol anticancer therapy,
* Incomplete initial staging.

Minimum Eligible Age

6 Months

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No