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
1 Year
21 Years
Both
Neuroblastoma
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Ruth Ladenstein, MD
Investigator Role:
Study Chair
Investigator Affiliation:
St. Anna Kinderkrebsforschung
Authority:
United States: Federal Government
Study ID:
CDR0000066861
NCT ID:
NCT00003743
Start Date:
March 1997
Completion Date:
Related Keywords:
- Neuroblastoma
- disseminated neuroblastoma
- Neuroblastoma
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