Interleukin-2 in Treating Children With Stage IV Neuroblastoma Who Have Received Induction Therapy and Peripheral Stem Cell Transplantation

Neuroblastoma Clinical Trial

Official title:

Multicenter Observer-Blind Randomized Phase II Parallel Study Comparing Three Doses of Subcutaneous Interleukin 2 After Megatherapy and Peripheral Stem Cell Reinfusion in Stage 4 Neuroblastoma in Patients Over 1 Year of Age

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003743
• Other study ID #: CDR0000066861
• Secondary ID: STANNACH-INTERLE
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 16, 2013
• Start date: March 1997

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES: I. Determine the maximum dose that can be administered in an ambulatory setting among three dose regimens in children with stage IV neuroblastoma. II. Determine the highest tolerated level if a sustained increase in NK-cell number is observed. III. Determine the type, duration, and reversibility of side effects at the three dose levels. IV. Confirm the chosen dose level.

OUTLINE: This is a randomized, parallel, open label, multicenter study. Part I: Patients receive one of three doses of interleukin-2 (IL-2) subcutaneously beginning 20 to 40 days following autologous stem cell reinfusion. IL-2 is administered for 5 consecutive days every 14 days for up to 3 months, for a total of 6 courses. Cohorts of 5 patients are entered at each dose level of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 or more patients experience dose limiting toxicity. Part II: Additional patients receive IL-2 at the dose level below the MTD. These patients are stratified according to prior therapy (melphalan plus megatherapy vs total body irradiation or meta-iodobenzylguanidine scan plus melphalan vs busulfan containing regimens). Patients are followed at 1 week.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Biological:
• aldesleukin

Locations

Country	Name	City	State
Austria	St. Anna Children's Hospital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
St. Anna Kinderkrebsforschung

Country where clinical trial is conducted

Austria,