Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

Conditions

• Ganglioneuroblastoma
• Recurrent Neuroblastoma

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Dinutuximab — BIOLOGICAL
  Given IV
• Irinotecan Hydrochloride — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Optional correlative studies
• Sargramostim — BIOLOGICAL
  Given SC or IV
• Temozolomide — DRUG
  Given PO
• Temsirolimus — DRUG
  Given IV

Study Details

This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving irinotecan hydrochloride and temozolomide together with temsirolimus or dinutuximab is more effective in treating neuroblastoma.

Key Dates

Start date

Feb 12, 2013

Status verified

Oct 2022

Primary completion

Jun 30, 2018

Completion

Sep 30, 2022

Study Design

Enrollment

73 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (temozolomide, irinotecan hydrochloride, temsirolimus)
  CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8.
• Experimental: Arm II (temozolomide, irinotecan hydrochloride, dinutuximab)
  Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12.

Primary Outcome Measure

Percentage of Randomized Patients Who Are Responders [ Time Frame: Up to the first 6 cycles of treatment ]

Locations (136)

Find similar trials in Phoenix, AZ

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