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

NCT01259479 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-07-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Satraplatin

Orally, once daily for 5 days repeated every 28 days, dose-escalation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Brigitte C Widemann, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-03
Primary Completion
2013-08-01
Completion
2015-05-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01259479 on ClinicalTrials.gov