Satraplatin in Children and Young Adults With Refractory Solid Tumors Including Brain Tumors
|ClinicalTrials.gov Identifier: NCT01259479|
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : October 6, 2017
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors Brain Tumors Brain Metastases||Drug: Satraplatin||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 3, 2010|
|Actual Primary Completion Date :||August 1, 2013|
|Actual Study Completion Date :||May 29, 2015|
Dose escalation, continuous treatment without DLTs
Orally, once daily for 5 days repeated every 28 days, dose-escalation
- MTD [ Time Frame: 1 Year ]
- PKs [ Time Frame: 1 Year ]
- Definte anti-tumore activity [ Time Frame: 1 Year ]
- PGs [ Time Frame: 1 Year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259479
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Brigitte C Widemann, M.D.||National Cancer Institute (NCI)|