|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Giselle Sholler |
|---|---|
| Collaborator: |
Archer Biosciences, Inc. |
| Information provided by (Responsible Party): | Giselle Sholler, Van Andel Research Institute |
| ClinicalTrials.gov Identifier: | NCT00867568 |
Purpose
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 |
|---|---|---|
|
Neuroblastoma Medulloblastoma Relapse |
Drug: TPI 287 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | June 2013 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: TPI 287 |
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.
|
Show Detailed Description
Eligibility| 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:
Contacts and Locations| United States, California | |
| Rady Children's Hospital | |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| Arnold Palmer Hospital for Children- MD Anderson | |
| Orlando, Florida, United States, 32806 | |
| United States, Missouri | |
| Cardinal Glennon Children's Medical Center | |
| St. Louis, Missouri, United States, 63104 | |
| United States, North Carolina | |
| Levine Children's Hospital | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Vermont | |
| UVM/FAHC | |
| Burlington, Vermont, United States, 05401 | |
| Study Chair: | Giselle Sholler, MD | Van Andel Research Institute |
More Information
| Responsible Party: | Giselle Sholler, Study Chair, Van Andel Research Institute |
| ClinicalTrials.gov Identifier: | NCT00867568 History of Changes |
| Other Study ID Numbers: | TPI-287 |
| Study First Received: | March 23, 2009 |
| Last Updated: | April 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Relapsed Neuroblastoma Refractory Neuroblastoma Relapsed Medulloblastoma Refractory Medulloblastoma |
|
Medulloblastoma Neuroblastoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neuroectodermal Tumors, Primitive Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neuroectodermal Tumors, Primitive, Peripheral Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |