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| Sponsored by: |
St. Anna Children's Hospital |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003743 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Drug: aldesleukin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| 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 |
| Estimated Enrollment: | 25 |
| Study Start Date: | March 1997 |
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.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
| Study ID Numbers: | CDR0000066861, STANNACH-INTERLEUKIN-2, EU-98056 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003743 |
| Health Authority: | United States: Federal Government |
|
disseminated neuroblastoma |
|
Neuroectodermal Tumors Aldesleukin Neuroectodermal Tumors, Primitive Interleukin-2 Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Neuroectodermal Tumors, Primitive, Peripheral Neuroblastoma Neoplasms, Glandular and Epithelial |
|
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Antiviral Agents Pharmacologic Actions Neoplasms |
Anti-Retroviral Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Neoplasms, Neuroepithelial Central Nervous System Agents |
