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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00428272 |
Purpose
RATIONALE: Monoclonal antibodies, such as lexatumumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Biological therapies, such as recombinant interferon-gamma, may stimulate the immune system in different ways and stop cancer cells from growing. Giving recombinant interferon-gamma together with lexatumumab may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lexatumumab alone and together with recombinant interferon gamma in treating young patients with solid tumors or lymphoma that have relapsed or not responded to treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer Lymphoma Neuroblastoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Biological: lexatumumab Biological: recombinant interferon gamma Genetic: protein expression analysis Other: flow cytometry Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study |
Phase I |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of Monoclonal Antibody HGS-ETR2 (Lexatumumab) With or Without Interferon Gamma in Patients With Refractory Pediatric Solid Tumors |
| Estimated Enrollment: | 73 |
| Study Start Date: | July 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label, dose-escalation study of lexatumumab.
Patients undergo blood collection periodically for pharmacokinetic studies. Blood serum is analyzed for concentration of lexatumumab via immunoenzyme techniques; anti-lexatumumab antibodies, TNF-related apoptosis-inducing ligand expression and caspase 8 expression, recombinant interferon gamma activity, lymphocyte storage, and immunogenicity via flow cytometry. Previously collected tissue samples are examined by immunohistochemistry for TR1, TR2, caspase 8, survivin, and bcl-2 expression.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 1 Year to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy, including, but not limited to, any of the following:
No primary or untreated metastatic CNS tumors
Patients with prior CNS metastases must meet the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Alexander J. Chou, MD 212-639-8895 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-2799 | |
| Principal Investigator: | Crystal Mackall, MD | NCI - Pediatric Oncology Branch |
More Information
| Study ID Numbers: | CDR0000526212, NCI-07-C-0040, NCI-P6981 |
| Study First Received: | January 25, 2007 |
| Last Updated: | January 20, 2010 |
| ClinicalTrials.gov Identifier: | NCT00428272 History of Changes |
| Health Authority: | Unspecified |
|
previously treated childhood rhabdomyosarcoma recurrent childhood rhabdomyosarcoma metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma recurrent/refractory childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma recurrent Wilms tumor and other childhood kidney tumors stage IV Wilms tumor stage V Wilms tumor metastatic osteosarcoma recurrent osteosarcoma disseminated neuroblastoma recurrent neuroblastoma metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor |
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor unspecified childhood solid tumor, protocol specific recurrent childhood large cell lymphoma stage IV childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma Burkitt lymphoma recurrent childhood small noncleaved cell lymphoma stage IV childhood small noncleaved cell lymphoma childhood grade III lymphomatoid granulomatosis recurrent childhood grade III lymphomatoid granulomatosis childhood nasal type extranodal NK/T-cell lymphoma childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma |
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Anti-Infective Agents Neuroectodermal Tumors, Primitive Interferon Type II Antineoplastic Agents Neoplasms, Nerve Tissue Urogenital Neoplasms Urologic Neoplasms Neuroblastoma Neoplasms, Connective and Soft Tissue Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Kidney Diseases |
Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Interferons Antiviral Agents Pharmacologic Actions Carcinoma Lymphatic Diseases Neuroectodermal Tumors Neoplasms Sarcoma Carcinoma, Renal Cell Adenocarcinoma Lymphoproliferative Disorders |