NCT01259479

Satraplatin in Children and Young Adults With Refractory Solid Tumors Including Brain Tumors

Completed Phase 1 Last updated 5 July 2018

What this trial tests

Phase 1 trial testing Satraplatin in Solid Tumors in 9 participants. Completed in 29 May 2015.

Timeline

3 December 2010

Primary endpoint
1 August 2013

29 May 2015

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	3 December 2010
Primary completion	1 August 2013
Estimated completion	29 May 2015
Sites	1 location across United States

Drugs / interventions tested

• Satraplatin — full drug profile →

Conditions studied

• Solid Tumors — all drugs for Solid Tumors →
• Brain Tumors — all drugs for Brain Tumors →
• Brain Metastases — all drugs for Brain Metastases →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 3 to 25, any sex, with Solid Tumors or Brain Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Metallodrugs are unique: opportunities and challenges of discovery and development.
   Anthony EJ, Bolitho EM, Bridgewater HE, Carter OWL, et al · · 2020 · cited 372× · PMID 34123239 · DOI 10.1039/d0sc04082g
2. From the Discovery of Targets to Delivery Systems: How to Decipher and Improve the Metallodrugs' Actions at a Molecular Level.
   Iacobucci I, La Manna S, Cipollone I, Monaco V, et al · · 2023 · cited 6× · PMID 37514183 · DOI 10.3390/pharmaceutics15071997