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Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma


Phase 2
N/A
18 Years
Not Enrolling
Both
Neuroblastoma

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Trial Information

Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma


All children will receive fixed doses of intravenous temsirolimus (50 mg/m2 weekly 6 times )
concomitantly with two courses of fixed dosages of irinotecan (20 mg/m2 intravenously daily
5 times ,2 days off, repeated daily 5 times .If these initial dosages are not tolerable then
subsequent patients will be given a reduced dosage of temsirolimus (25 mg/m2 weekly 6 times)
with 20 mg/m2 of irinotecan.If this dosage combination is not tolerable, the irinotecan
dosage will be decreased to 15 mg/m2 .If this dosage combination is not tolerable then
further enrollment to the initial six week treatment will be terminated.The second course of
irinotecan will begin on day 22 and response will be determined after six weeks (two
courses). Resection of primary tumor will be attempted after this initial therapy, whenever
possible.

Following initial treatment children will undergo alternating courses of induction
chemotherapy with cyclophosphamide, doxorubicin, etoposide, topotecan, and cisplatin (Block
2). The first cohort of 17 patients will receive Block 2 with temsirolimus (50mg/m2) for all
three courses, weekly 2 times. If this is not tolerated subsequent patients will receive
Block 2 chemotherapy with reduced dosages of temsirolimus (25mg/m2).


Inclusion Criteria:



- Patients <18 years old with newly diagnosed, advanced stage, high-risk neuroblastoma
defined as one of the following:

- Children < 1 yo with International Neuroblastoma Staging System (INSS) stage 2a,
2b, 3, 4 or 4S disease and MYCN amplification (>10 copies, or greater than
four-fold increase in MYCN signal as compared to reference signal)

- INSS 2a or 2b disease and MYCN amplification, regardless of age or additional
biologic features

- INSS stage 3 and:

1. MYCN amplification (>10 copies, or greater than four-fold increase in MYCN
signal as compared to reference signal, regardless of age or additional
biologic features

2. Age > 18 mo (> 547 days) with unfavorable pathology, regardless of MYCN
status

- INSS stage 4 and:

1. MYCN amplification, regardless of age or additional biologic features

2. Age > 18 months (> 547 days) regardless of biologic features

3. Age 12 - 18 months (365 - 547 days) with any of the following three
unfavorable biologic features (MYCN amplification, unfavorable pathology
and/or DNA index =1) or any biologic feature that is indeterminant/unknown

- Children less than or equal to 365 days initially diagnosed with: INSS stage 1,
2, 4S who progressed to a stage 4 without interval chemotherapy.

- Histologic proof of neuroblastoma or positive bone marrow for tumor cells with
increased urine catecholamines.

- Adequate renal and hepatic function (serum creatinine <3 x upper limit of normal for
age, (AST) aspartate aminotransferase < 3 x upper limit of normal).

- No prior therapy, unless an emergency situation requires local tumor treatment
(discuss with PI)

- Written, informed consent according to institutional guidelines

Exclusion Criteria:

- Any evidence, as judged by the investigator, of severe or uncontrolled systemic
disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal
disease).

- Pregnant or breast feeding (women of child-bearing potential).

- Children with INSS 4 disease, age <12 months with all 3 favorable biologic features
(non-amplified MYCN, favorable pathology and DNA index >1).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Response Plus Partial Response

Outcome Description:

The objective was to measure the efficacy and feasability of Temsirolimus and Irinotecan as measured by the objective response rate and toxicity rate.

Outcome Time Frame:

10 years

Safety Issue:

Yes

Principal Investigator

Wayne L Furman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NB2008

NCT ID:

NCT00808899

Start Date:

December 2008

Completion Date:

July 2009

Related Keywords:

  • Neuroblastoma
  • Neuroblastoma
  • Neuroblastoma

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794