Satraplatin in Children and Young Adults With Refractory Solid Tumors Including Brain Tumors
This study has been completed.
Information provided by:
National Institutes of Health Clinical Center (CC)
First received: December 11, 2010
Last updated: December 7, 2013
Last verified: August 2013
- Cisplatin and carboplatin are standard cancer treatment drugs used for various childhood cancers, including brain tumors. Both drugs frequently have severe side effects that may reduce their effectiveness, particularly in children, and new treatments are needed that may be similarly effective but less toxic for cancer patients.
- Satraplatin is an experimental drug, similar to cisplatin and carboplatin, that has not yet been approved by the Food and Drug Administration. Satraplatin has been shown to treat cancer by interfering with genetic material (DNA) in cancer cells. Some adults with cancer who have received satraplatin had slowing of the growth or shrinkage of their tumor. Researchers are interested in determining whether satraplatin can be effective for cancers that occur in children.
- To evaluate the safety and effectiveness of satraplatin as a treatment for children and young adults who have solid tumors that have not responded to standard treatment.
- To study the effects of satraplatin on the body in terms of side effects and blood chemistry.
- To examine the effect that genetic variations may have on the effectiveness of satraplatin.
- Children, adolescents, and young adults between 3 and 21 years of age who have solid tumors (including brain tumors) that have not responded to standard treatment.
- Participants will be screened with a full physical examination and medical history, blood tests, and tumor imaging studies.
- Participants will receive satraplatin pills to be taken every day in the morning for 5 consecutive days, with no food for 2 hours before or 1 hour after the dose. Participants will then have 23 days without the drug to complete a 28-day cycle of treatment. Participants will also receive medication to prevent nausea and vomiting 30 minutes before the first dose of satraplatin. Following the first dose of satraplatin, medication for nausea will be given if needed.
- Satraplatin doses will be adjusted based on response to treatment, including potential side effects. Participants will have frequent blood tests and imaging studies to evaluate the effectiveness of the treatment and monitor any side effects, as well as hearing tests and other examinations as required by the study researchers.
- Participants will receive satraplatin every 4 weeks for up to 2 years until serious side effects occur or the tumor stops responding to treatment.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial and Pharmacokinetic Study of the Oral Platinum Analog Satraplatin in Children and Young Adults With Refractory Solid Tumors Including Brain Tumors|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
- To determine the maximum tolerated dose (MTD) of oral satraplatin administered on a once daily for 5 days every 28 days schedule in pediatric patients with relapsed or refractory solid tumors including brain tumors.
Secondary Outcome Measures:
- Define toxicities of satraplatin and characterize the pharmacokinetics in refractory cancer
- Determine the preliminary antitumor activity in refractory cancer
- Evaluate the pharmacogenomic expression of DNA repair genes peripheral blood mononuclear blood cells.
|Study Start Date:||December 2010|
|Study Completion Date:||August 2013|
Intervention Details:Show Detailed Description
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259479
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
Sponsors and Collaborators
|Principal Investigator:||Brigitte C Widemann, M.D.||National Cancer Institute (NCI)|