NCT00005602

Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas

Completed Phase 1 Last updated 19 February 2014

What this trial tests

Phase 1 trial testing carboplatin in Brain and Central Nervous System Tumors in 13 participants. Completed in 1 September 2005.

Timeline

1 February 2001

Primary endpoint
1 January 2005

1 September 2005

Quick facts

Lead sponsor	Children's Oncology Group
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	13
Start date	1 February 2001
Primary completion	1 January 2005
Estimated completion	1 September 2005
Sites	19 locations across United States

Drugs / interventions tested

• carboplatin (Carboplatin) — full drug profile →
• cereport — full drug profile →
• radiation therapy — full drug profile →

Conditions studied

• Brain and Central Nervous System Tumors — all drugs for Brain and Central Nervous System Tumors →

Sponsor

Children's Oncology Group — full company profile →

Who can join

Adults 3 to 21, any sex, with Brain and Central Nervous System Tumors. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression Free Survival
  A MRI scan will be performed six (6) weeks after completion of radiation, plus at three-month intervals thereafter for two years, as long as there is no evidence of progressive disease. Children who are progression-free two years after treatment will have MRI scanning at six-month intervals, thereafter, for three more years

Sponsor's own description

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy.

PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.

Publications & conference data

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

1. Peptide-Based Agents for Cancer Treatment: Current Applications and Future Directions.
   Nhàn NTT, Yamada T, Yamada KH. · · 2023 · cited 63× · PMID 37629112 · DOI 10.3390/ijms241612931
2. IL-17 Receptor Signaling Negatively Regulates the Development of Tubulointerstitial Fibrosis in the Kidney.
   Ramani K, Tan RJ, Zhou D, Coleman BM, et al · · 2018 · cited 24× · PMID 30405320 · DOI 10.1155/2018/5103672