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Sponsors and Collaborators: |
University of Vermont Archer Biosciences, Inc. |
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Information provided by: | University of Vermont |
ClinicalTrials.gov Identifier: | NCT00867568 |
The purpose of this research study is to evaluate a new investigational drug (TPI 287) for neuroblastoma and medulloblastoma both alone and in combination with temozolomide (a currently approved drug). An investigational drug is one that has not yet been approved by the Food and Drug Administration. This investigational drug is called TPI 287. This study will look at the safety and tolerability of TPI 287 both alone and in combination with temozolomide, and look to establish a safe dose of this agent. The study will also look at the tumor's response to these drugs, but this is not the primary objective of this study. TPI 287 was shown to be effective in stopping tumor growth and was also shown to be safe in three different animal species. TPI 287 has been tested in humans in four clinical trials, and approximately 100 subjects with various types of cancers have received the drug. All of these subjects that have received TPI 287 have been adults. TPI 287 has not been tested in a pediatric population before this study.
Temozolomide was tested in recurrent neuroblastoma and showed activity in a recently published study. Preclinical studies of TPI in combination with temozolomide have shown at minimum an additive effect. The ability of temozolomide and TPI 287 to be effective in combination is suggested by these two drugs showing even greater activity when used together.
Condition | Intervention | Phase |
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Relapsed Neuroblastoma Refractory Neuroblastoma Relapsed Medulloblastoma Refractory Medulloblastoma |
Drug: TPI 287 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase 1 Trial of TPI 287 as a Single Agent and in Combination With Temozolomide in Patients With Refractory or Recurrent Neuroblastoma or Medulloblastoma |
Estimated Enrollment: | 24 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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TPI 287: Experimental |
Drug: TPI 287
Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
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Ages Eligible for Study: | 12 Months to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate liver function must be demonstrated, defined as:
Exclusion Criteria:
Contact: Genevieve Bergendahl, RN | 803-656-4511 | genevieve.bergendahl@uvm.edu |
United States, California | |
Rady Children's Hospital | Not yet recruiting |
San Diego, California, United States, 92123 | |
Contact: Lori Murphy 800-788-9029 | |
Principal Investigator: William Roberts, MD | |
United States, Missouri | |
St. Louis University | Not yet recruiting |
St. Louis, Missouri, United States, 63104 | |
Contact: Katherine Maxwell, RN 314-268-4000 | |
Principal Investigator: William Ferguson, MD | |
United States, Vermont | |
UVM/FAHC | Recruiting |
Burlington, Vermont, United States, 05401 | |
Contact: Genevieve Bergendahl, RN 802-656-4511 genevieve.bergendahl@uvm.edu | |
Principal Investigator: Giselle Sholler, MD | |
Sub-Investigator: Alan Homans, MD |
Principal Investigator: | Giselle Sholler, MD | University of Vermont |
Responsible Party: | University of Vermont ( Giselle Sholler, MD, Assistant Professor of Pediatrics ) |
Study ID Numbers: | TPI-287 |
Study First Received: | March 23, 2009 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00867568 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neuroectodermal Tumors, Primitive Temozolomide Neuroblastoma Recurrence Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Medulloblastoma |
Neuroepithelioma Glioma Antineoplastic Agents, Alkylating Alkylating Agents Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Temozolomide Pharmacologic Actions Neuroblastoma Neuroectodermal Tumors Neoplasms |
Therapeutic Uses Neoplasms, Germ Cell and Embryonal Medulloblastoma Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Alkylating Agents Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |