National Cancer Institute - U.S. National Institutes of Health - www.cancer.govSkip navigationNational Cancer Institute - U.S. National Institutes of Health - www.cancer.govClinical Trials at NIH - Be part of the cure
National Cancer Institute - U.S. National Institutes of Health - www.cancer.gov
Clinical Trials at NIH Home

Search for CCR Trials at NIH


Pediatric Cancers

Phase I Trial and Pharmacokinetic Study of the Oral Platinum Analog Satraplatin in Children and Young Adults With Refractory Solid Tumors Including Brain Tumors

NCI-11-C-0047, NCT01259479

Print this page 


Investigator(s):

Brigitte Widemann, M.D.
Principal Investigator
Phone: 301-496-7387
widemanb@mail.nih.gov

Referral Contact(s):

Pediatric Oncology
Phone: 301-496-4256
1-877-624-4878 (Toll free)

 

Background:

  • The platinum compounds cisplatin and carboplatin are standard agents in the treatment of a variety of childhood cancers; however, cumulative and long-term renal and ototoxicity are a concern related to cisplatin administration, particularly in young children
  • Several mechanisms of resistance to platinum compounds have been described, including decreased drug accumulation due to altered drug uptake or the presence of a membrane efflux pump, increased intracellular levels of thiol-containing groups that detoxify and modulate platinum, and removal of the platinum-DNA adducts by DNA repair pathways called nucleotide excision repair (NER) and base excision repair (BER) pathways
  • Polymorphisms in DNA repair genes have been shown in some cancers to predict better treatment response to platinum treatment
  • Satraplatin is an oral platinum analog with similar preclinical in vitro and in vivo activity to that of cisplatin and carboplatin and with activity in platinum resistant models
  • Dose-limiting satraplatin toxicities in adults including nausea, vomiting, and myelosuppression; neither renal nor neurologic toxicities have been described
  • Satraplatin has demonstrated clinical activity in adult refractory tumors at the recommended Phase II and III dose of 80 mg/m2/dose daily x 5 days every 28 or 35 days

Objectives:

  • Determine the maximum tolerated dose (MTD) of oral satraplatin administered on a once daily x 5 days every 28 days schedule in pediatric patients with relapsed or refractory solid tumors, including brain tumors
  • Define the toxicities of oral satraplatin and characterize the pharmacokinetics of oral satraplatin in children with refractory cancer
  • Determine the preliminary antitumor activity of satraplatin
  • Evaluate the pharmacogenomic expression of DNA repair genes in peripheral blood mononuclear blood cells

Key Eligibility Criteria:

  • > 3 years and ≤ 21 years of age
  • Relapsed or refractory solid tumors, including brain tumors
  • Adequate organ function

Study Outline:

  • This is a Phase I trial of satraplatin administered once daily orally x 5 days every 28 days, a cycle of therapy is considered to be 28 days
  • The starting dose level is 60 mg/m2/dose, with escalations to 80, 110, 140 mg/m2/dose
  • The MTD will be defined based on satraplatin tolerability during cycle one
  • Disease status will be evaluated prior to every odd treatment cycle and therapy may continue for up to 2 years in the absence of progressive disease or unacceptable toxicity
  • Plasma pharmacokinetics and pharmacogenomics will be evaluated during the first treatment cycle

Additional Information:

  • This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
  • There is no charge for medical care received at NIH Clinical Center.
  • PDQ (Physicians Data Query) - provides additional details about this study for health care providers.


Reviewed: 12/14/12
Updated: 5/20/11

Back to Top
Health and Human Services National Institutes of Health National Cancer Institute USA.gov