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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303940 |
RATIONALE: Talabostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Drugs used in chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving talabostat together with temozolomide or carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of talabostat when given together with temozolomide or carboplatin in treating young patients with relapsed or refractory brain tumors or other solid tumors.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: carboplatin Drug: talabostat mesylate Drug: temozolomide Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial and Pharmacokinetic Study of Talabostat (PT-100, Val-Boro-Pro) in Combination With Temozolomide or Carboplatin in Pediatric Patients With Relapsed or Refractory Solid Tumors Including Brain Tumors |
Estimated Enrollment: | 26 |
Study Start Date: | December 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of talabostat. Patients are stratified according to tumor histology and prior therapy.
Based on stratification, patients receive either oral temozolomide on days 1-5 or carboplatin IV over 30 minutes on days 1-2. Patients also receive oral talabostat on days 7-20. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. (Closed to accrual as of 5/25/2009)
Cohorts of 2-6 patients receive escalating doses of talabostat 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 during the first course of therapy.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
Ages Eligible for Study: | 2 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumors, including, but not limited to, any of the following:
Primary brain tumors
In patients with brainstem or optic gliomas, requirement for histological confirmation can be waived if biopsy was not performed
Relapsed or failed to respond to frontline curative therapy, including any of the following:
PATIENT CHARACTERISTICS:
Creatinine clearance ≥ 60 mL/min OR age-adjusted creatinine* as follows:
No clinically significant, unrelated systemic illness, including either of the following:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Holly Meany, MD | NCI - Pediatric Oncology Branch |
Principal Investigator: | Elizabeth Fox, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000462620, NCI-05-C-0239, NCI-P6672 |
Study First Received: | March 15, 2006 |
Last Updated: | June 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00303940 History of Changes |
Health Authority: | United States: Food and Drug Administration |
unspecified childhood solid tumor, protocol specific recurrent childhood rhabdomyosarcoma recurrent childhood soft tissue sarcoma recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent osteosarcoma recurrent neuroblastoma recurrent Wilms tumor and other childhood kidney tumors recurrent childhood malignant germ cell tumor recurrent childhood liver cancer recurrent childhood brain stem glioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood ependymoma recurrent childhood medulloblastoma recurrent childhood supratentorial primitive neuroectodermal tumor |
childhood atypical teratoid/rhabdoid tumor childhood low-grade cerebral astrocytoma childhood high-grade cerebral astrocytoma childhood choroid plexus tumor childhood craniopharyngioma childhood infratentorial ependymoma childhood supratentorial ependymoma childhood oligodendroglioma recurrent childhood visual pathway and hypothalamic glioma recurrent childhood brain tumor childhood central nervous system germ cell tumor childhood grade I meningioma childhood grade II meningioma childhood grade III meningioma childhood malignant ovarian germ cell tumor |
Liver Diseases Neuroectodermal Tumors, Primitive Urogenital Neoplasms Central Nervous System Neoplasms Brain Diseases Urologic Neoplasms Neoplasms, Connective and Soft Tissue Wilms' Tumor Osteogenic Sarcoma Neuroepithelioma Ovarian Cancer Glioma Kidney Diseases Nervous System Neoplasms Rhabdomyosarcoma |
Endocrine Gland Neoplasms Digestive System Neoplasms Testicular Cancer Astrocytoma Genital Neoplasms, Female Endocrine System Diseases Carboplatin Testicular Neoplasms Temozolomide Ewing's Sarcoma Carcinoma Brain Neoplasms Neuroectodermal Tumors Brain Stem Glioma, Childhood Malignant Mesenchymal Tumor |
Liver Diseases Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Neoplasms, Nerve Tissue Urogenital Neoplasms Ovarian Diseases Central Nervous System Neoplasms Brain Diseases Urologic Neoplasms Neuroblastoma Genital Diseases, Female Liver Neoplasms Neoplasms, Connective and Soft Tissue |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Kidney Diseases Alkylating Agents Nervous System Neoplasms Endocrine Gland Neoplasms Ovarian Neoplasms Neoplasms by Histologic Type Digestive System Neoplasms Nervous System Diseases Genital Neoplasms, Female Endocrine System Diseases |