Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Baylor College of Medicine NEW APPROACHES TO NEUROBLASTOMA THERAPY (NANT) CONSORTIUM |
---|---|
Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00206388 |
The purposes of this study are:
Condition | Intervention | Phase |
---|---|---|
Neuroblastoma |
Drug: Zolendric acid Drug: Cyclophosphamide |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Zoledronic Acid (Zometa) With Cyclophosphamide in Children With Recurrent or Refractory Neuroblastoma and Cortical Bone Involvement (NANT 2004-01) |
Estimated Enrollment: | 24 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | August 2009 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Zoledronic Acid (Zometa), a new generation, highly potent bisphosphonate used to treat osteoporosis and hypercalcemia of malignancy, is widely used in adult malignancies with potential for bone metastasis such as breast cancer, multiple myeloma and prostate cancer. Bisphosphonates modulate the bone environment by toxicity to osteoclasts resulting in decreased bone resorption. Zometa is the first bisphosphonate to affect both osteolytic and osteoblastic metastatic lesions. In several large randomized studies in adults with recurrent or advanced malignancies, patients randomized to Zometa had delay in progression of bone metastases and less morbidity (skeletal related events) when compared to either placebo or pamidronate. The toxicity profile of Zometa in adults has been tolerable and includes hypocalcemia, temperature rise, and nausea. The most concerning toxicity is decline in renal function that appears to be related to cumulative dose and the dose rate of administration. In our pre-clinical studies bisphosphonates delayed progression of osteolytic lesions in neuroblastoma tumors xenografted into immunocompromised mice while the combination of Zometa with low dose cyclophosphamide appeared to prolong overall survival. The primary aim of this study is to evaluate the maximum tolerated dose of Zometa combined with low dose oral cyclophosphamide in children with recurrent or refractory neuroblastoma. We will also evaluate the pharmacokinetics of Zometa in children with neuroblastoma and examine the effect of Zometa on markers of bone resorption, cytokines and bone-related growth factors.
Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients in this category are REQUIRED to have a biopsy of at least one residual site demonstrating viable neuroblastoma.
Age-adjusted normal serum creatinine for age Adequate Liver Function a. Total bilirubin less than or equal to 1.5 x normal for age, and b. SGPT (ALT) and SGOT (AST) less than 5 x normal for age.
Exclusion Criteria:
United States, California | |
Children's Hospital Los Angeles | |
Los Angeles, California, United States, 90027 | |
USCF School of Medicine | |
San Francisco, California, United States, 94143 | |
Lucille Salter Packer Children's Hospital | |
Stanford, California, United States, 94305 | |
United States, Indiana | |
Indiana University-Riley Children's Hospital | |
Indianapolis, Indiana, United States, 46202 | |
United States, Ohio | |
Cincinnati Children's Hospital | |
Cincinnati, Ohio, United States, 45229 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Texas Children's Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Wisconsin | |
University of Wisconsin Medical Center | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | HEIDI V RUSSELL, MD | Baylor College of Medicine |
Responsible Party: | Baylor College of Medicine ( Heidi Russell, MD ) |
Study ID Numbers: | 16758, ZOMETA |
Study First Received: | September 14, 2005 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00206388 History of Changes |
Health Authority: | United States: Food and Drug Administration |
NEUROBLASTOMA RECURRENT REFRACTORY CORTICAL BONE |
Neuroectodermal Tumors, Primitive Zoledronic acid Immunologic Factors Bone Density Conservation Agents Cyclophosphamide Immunosuppressive Agents Neuroblastoma Recurrence |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Zoledronic acid Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Bone Density Conservation Agents Cyclophosphamide Immunosuppressive Agents Pharmacologic Actions |
Neuroblastoma Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Neoplasms, Neuroepithelial Alkylating Agents Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |