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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020514 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Tariquidar may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drug.
PURPOSE: This phase I trial is studying the effectiveness of tariquidar plus chemotherapy in treating children who have relapsed or refractory solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Biological: filgrastim Drug: docetaxel Drug: doxorubicin hydrochloride Drug: tariquidar Drug: vinorelbine ditartrate Other: pharmacological study |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Trial and Pharmacokinetic Study of Tariquidar (XR9576), A P-Glycoprotein Inhibitor, in Combination With Doxorubicin, Vinorelbine or Docetaxel in Pediatric Patients With Refractory Solid Tumors Including Brain Tumors |
| Estimated Enrollment: | 36 |
| Study Start Date: | March 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of tariquidar.
Patients receive tariquidar IV over 30 minutes on days -1 and 1 of course 1 and on day 1 of all subsequent courses. Patients also receive one of the following: doxorubicin IV over 15 minutes on day 1; vinorelbine IV over 10 minutes on days 1 and 8; or docetaxel IV over 60 minutes on day 1. Patients receiving doxorubicin or docetaxel also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 3 and continuing until blood counts recover. Patients receiving vinorelbine also receive G-CSF SC beginning on day 10 and continuing until blood counts recover. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tariquidar until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. An additional 18 patients (at least 3 under age 12 and at least 3 who are age 12 and older) are treated at the MTD. Intrapatient dose escalation may take place for patients in cohorts 1 and 2 after 2 courses of treatment.
Patients undergo blood collection periodically for pharmacokinetic and pharmacodynamic studies.
Patients are followed every 6 weeks for 1 year and then every 12 weeks during study treatment.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor, including, but not limited to the following tumor types:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
All patients:
Patients receiving doxorubicin on study must meet 1 of the following criteria:
Endocrine therapy:
Radiotherapy:
Other:
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-4318 | |
| Study Chair: | Elizabeth Fox, MD | NCI - Pediatric Oncology Branch |
More Information
| Study ID Numbers: | CDR0000068563, NCI-01-C-0091 |
| Study First Received: | July 11, 2001 |
| Last Updated: | September 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00020514 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
metastatic osteosarcoma childhood infratentorial ependymoma recurrent childhood rhabdomyosarcoma childhood supratentorial ependymoma childhood craniopharyngioma disseminated neuroblastoma stage 4S neuroblastoma recurrent neuroblastoma stage IV childhood liver cancer recurrent childhood liver cancer stage IV Wilms tumor stage V Wilms tumor recurrent Wilms tumor and other childhood kidney tumors childhood central nervous system germ cell tumor recurrent osteosarcoma |
unspecified childhood solid tumor, protocol specific childhood germ cell tumor metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma childhood high-grade cerebral astrocytoma childhood oligodendroglioma childhood choroid plexus tumor childhood grade I meningioma childhood grade II meningioma childhood grade III meningioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma recurrent childhood visual pathway and hypothalamic glioma previously treated childhood rhabdomyosarcoma |
|
Liver Diseases Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Urogenital Neoplasms Vinblastine Central Nervous System Neoplasms Urologic Neoplasms Docetaxel Neoplasms, Connective and Soft Tissue Neoplasms by Site Therapeutic Uses Kidney Diseases Nervous System Neoplasms Endocrine Gland Neoplasms Digestive System Neoplasms |
Nervous System Diseases Genital Neoplasms, Female Endocrine System Diseases Doxorubicin Carcinoma Neuroectodermal Tumors Neoplasms Vinorelbine Sarcoma Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial Gonadal Disorders Antineoplastic Agents Neoplasms, Nerve Tissue |