NCT00003743

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill neuroblastoma cells. PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating children with stage IV neuroblastoma who have received induction therapy and peripheral stem cell transplantation.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1997

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

July 16, 2004

Completed
Last Updated

September 17, 2013

Status Verified

May 1, 2007

First QC Date

November 1, 1999

Last Update Submit

September 16, 2013

Conditions

Neuroblastoma

Keywords

disseminated neuroblastoma

Interventions

aldesleukinBIOLOGICAL

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: Histologically proven stage IV neuroblastoma At least stable disease after modern induction regimens and megatherapy followed by autologous stem cell reinfusion PATIENT CHARACTERISTICS: Age: Over 1 Performance status: Lansky 80-100% Life expectancy: Not specified Hematopoietic: Lymphocyte count at least 500/mm3 Platelet count at least 30,000/mm3 Hemoglobin at least 8 g/dL (at least 1 week since transfusional support) Blood coagulation less than 25% above upper limit of normal (ULN) for age (WHO grade 0) Hepatic: Bilirubin less than 25% above ULN for age (WHO grade 0) Renal: Creatinine less than 25% above ULN for age (WHO grade 0) Cardiovascular: No significant history or current evidence of cardiovascular disease (e.g., uncontrolled hypertension, serious arrhythmias) Normal shortening fraction at cardiac ultrasonography Normal ECG Other: No evidence of active infections Normal chest x-ray Normal brain CT scan No other concurrent disease or second primary malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No other concurrent immunotherapy Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids or other hormonal therapy Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: At least 30 days since prior investigational drugs or devices No concurrent investigational drugs, agents, or devices

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

St. Anna Children's Hospital

Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Ruth Ladenstein, MD

    St. Anna Kinderkrebsforschung

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 16, 2004

Study Start

March 1, 1997

Last Updated

September 17, 2013

Record last verified: 2007-05

Locations

AU(1)