Satraplatin in Children and Young Adults With Refractory Solid Tumors Including Brain Tumors
Status:
Completed
Trial end date:
2015-05-29
Target enrollment:
Participant gender:
Summary
Background:
- 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.
Objectives:
- 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.
Eligibility:
- 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.
Design:
- 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.