Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003750 |
RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I trial to study the effectiveness of hu14.18-interleukin-2 fusion protein in treating children who have refractory or recurrent neuroblastoma or other tumors.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) Neuroblastoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Biological: hu14.18-IL2 fusion protein |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/IB Intergroup Trial of the HU14.18-IL2 Fusion Protein in Children With Refractory Neuroblastoma and Other GD2 Positive Tumors |
Estimated Enrollment: | 24 |
Study Start Date: | May 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive hu14.18-interleukin-2 (hu14.18-IL2) fusion protein IV over 4 hours once daily on days 1-3.
Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of hu14.18-IL2 fusion protein until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 2 months for 1 year, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed neuroblastoma or melanoma at original diagnosis
Histologically confirmed tumor expressing GD2 antigen at original diagnosis or relapse
Prior CNS metastases allowed, provided:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Paul M. Sondel, MD, PhD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000066870, COG-ADVL0018 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003750 History of Changes |
Health Authority: | United States: Federal Government |
metastatic osteosarcoma recurrent neuroblastoma recurrent osteosarcoma recurrent melanoma |
unspecified childhood solid tumor, protocol specific metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma |
Neuroectodermal Tumors, Primitive Immunologic Factors Neuroblastoma Melanoma Antibodies, Monoclonal Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Osteogenic Sarcoma Neuroepithelioma Analgesics Immunoglobulins |
Osteosarcoma Recurrence Neuroendocrine Tumors Neuroectodermal Tumors Malignant Mesenchymal Tumor Antibodies Interleukin-2 Analgesics, Non-Narcotic Sarcoma Peripheral Nervous System Agents Nevus Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors, Primitive Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Neuroblastoma Melanoma Antibodies, Monoclonal Neoplasms, Connective and Soft Tissue Sensory System Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas Analgesics |
Neoplasms by Histologic Type Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Interleukin-2 Analgesics, Non-Narcotic Sarcoma Peripheral Nervous System Agents Neoplasms, Neuroepithelial Central Nervous System Agents Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |