Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma

Conditions

• Neuroblastoma

Eligibility Criteria

Sex

ALL

Age

N/A - 21 Years

Healthy Volunteers

Not accepted

Interventions

• irinotecan hydrochloride — DRUG
  Given IV
• temozolomide — DRUG
  Given IV

Study Details

RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with temozolomide works in treating young patients with recurrent neuroblastoma.

Key Dates

Start date

Apr 30, 2006

Status verified

Sep 2014

Primary completion

Mar 31, 2009

Completion

Dec 31, 2013

Study Design

Enrollment

59 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Disease measurable by CT or MRI scan (Irinotecan/Temozolomide)
  Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Disease eval by bone marrow or MIBG (Irinotecan/Temozolomide)
  Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) [ Time Frame: up to 6 courses of therapy, or about 6 months ]

Locations (110)

Find similar trials in Birmingham, AL

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