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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00437047 |
RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of trabectedin in treating young patients with solid tumors that have relapsed or not responded to treatment.
Condition | Intervention | Phase |
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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 |
Drug: filgrastim Drug: pegfilgrastim Drug: trabectedin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial and Pharmacokinetic Study of Trabectedin (Yondelis®, ET-743) in Children and Adolescents With Relapsed or Refractory Solid Tumors |
Estimated Enrollment: | 24 |
Study Start Date: | June 2008 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive trabectedin IV over 24 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 3 and continuing until blood counts recover OR pegfilgrastim SC once on day 3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-12 patients receive escalating doses of trabectedin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 4 of 12 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Ages Eligible for Study: | 4 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor, including, but not limited to, any of the following:
Brain tumors
PATIENT CHARACTERISTICS:
Creatinine clearance ≥ 60 mL/min OR age-adjusted creatinine meeting the following criteria:
PRIOR CONCURRENT THERAPY:
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 |
Principal Investigator: | Elizabeth Fox, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000529908, NCI-07-C-0054 |
Study First Received: | February 15, 2007 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00437047 |
Health Authority: | Unspecified |
unspecified childhood solid tumor, protocol specific recurrent childhood brain stem glioma recurrent childhood cerebellar astrocytoma childhood atypical teratoid/rhabdoid tumor previously treated childhood rhabdomyosarcoma recurrent childhood rhabdomyosarcoma metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor metastatic osteosarcoma recurrent osteosarcoma disseminated neuroblastoma recurrent neuroblastoma recurrent Wilms tumor and other childhood kidney tumors stage IV Wilms tumor stage V Wilms tumor |
recurrent childhood liver cancer stage IV childhood liver cancer childhood central nervous system germ cell tumor childhood extragonadal germ cell tumor childhood malignant ovarian germ cell tumor childhood malignant testicular germ cell tumor recurrent childhood malignant germ cell tumor childhood choroid plexus tumor childhood craniopharyngioma childhood infratentorial ependymoma childhood supratentorial ependymoma childhood teratoma childhood oligodendroglioma childhood grade I meningioma childhood grade II meningioma |
Ecteinascidin 743 Liver Diseases Neuroectodermal Tumors, Primitive Malignant mesenchymal tumor Urogenital Neoplasms Central Nervous System Neoplasms Urologic Neoplasms Osteogenic sarcoma Neoplasms, Connective and Soft Tissue Ewing's sarcoma Neuroepithelioma Glioma Kidney Diseases Nervous System Neoplasms Rhabdomyosarcoma |
Endocrine Gland Neoplasms Digestive System Neoplasms Astrocytoma Genital Neoplasms, Female Endocrine System Diseases Renal cancer Testicular Neoplasms Rhabdoid tumor Carcinoma Brain Neoplasms Neuroectodermal Tumors Sarcoma Gastrointestinal Neoplasms Testicular cancer Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Neoplasms, Nerve Tissue Pharmacologic Actions Adnexal Diseases |
Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents |