Satraplatin in Children and Young Adults With Refractory Solid Tumors Including Brain Tumors
Completed · Phase 1
Conditions studied: Solid Tumors, Brain Tumors, Brain Metastases
In brief
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.
Key facts
- Study ID
- NCT01259479
- Run by
- National Cancer Institute (NCI)
- People needed
- 9
- Starts
- 2010-12-03
- Expected to finish
- 2015-05-29
- Last updated by the study team
- 2018-07-05
Who can join
Age: 3 and older, up to 25. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Pregnant or breast-feeding females are excluded due to potential risks of fetal and teratogenic adverse events of an investigational agent. Pregnancy tests (urine BhCG) must be obtained prior to enrollment on this study in girls, age 9 years or older. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Abstinence is an acceptable method of birth control.
- Last dose of any investigational agent given within the past 30 days. 3. Ongoing radiation therapy, chemotherapy, hormonal therapy directed at the tumor, immunotherapy, or biologic therapy.
- Active graft versus host disease.
- Graft vs Host Disease (GVHD) therapy or agents to prevent organ rejection post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either GVHD post bone marrow transplant or organ rejection post transplant are not eligible for this trial.
- Clinically significant uncontrolled unrelated systemic illness such as serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction.
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
- Inability to swallow capsules as capsules cannot be crushed or broken
- Prior treatment with satraplatin.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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