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Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma

Study:

Feasibility/Phase II Study of hu14.18-IL2 Immunocytokine + GM-CSF and Isotretinoin in Patients With Relapsed or Refractory Neuroblastoma

Rationale:

Biological therapy and sargramostim, work in different ways to stimulate the immune system and stop tumor cells from growing. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving biological therapy together with sargramostim and isotretinoin may kill more tumor cells.

Purpose:

This phase II trial is studying how well hu14.18-IL2 fusion protein works when given together with sargramostim and isotretinoin in treating patients with relapsed or refractory neuroblastoma. Biological therapy, such as hu14.18-IL2 fusion protein, and sargramostim work in different ways to stimulate the immune system and stop tumor cells from growing. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hu14.18-IL2 fusion protein together with sargramostim and isotretinoin may kill more tumor cells.

Study Status: Active, not recruiting

Recruiting:
n/a

Condition Intervention Phase
Recurrent Neuroblastoma Biological: hu14.18-IL2 fusion protein
Drug: isotretinoin
Biological: sargramostim
Other: laboratory biomarker analysis
Phase 2

Verified by Children`s Oncology Group June, 2013

Sponsored by: Children`s Oncology Group
Information provided by: Children`s Oncology Group
ClinicalTrials.gov identifier: NCT01334515

Study Type: Interventional

Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Suzanne Shusterman., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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