NCT00628732

A Pharmacokinetic and Phase II Study of Oral Cyclophosphamide and Oral Topotecan in Children With Recurrent and or Refractory Solid Tumors

Completed Phase 2 Last updated 27 January 2009

What this trial tests

Phase 2 trial testing Cyclophosphamide and Topotecan in Solid Tumors in 36 participants. Completed in 1 February 2007.

Timeline

1 January 2005

Primary endpoint
1 February 2007

1 February 2007

Quick facts

Lead sponsor	Children's Medical Center Dallas
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	1 January 2005
Primary completion	1 February 2007
Estimated completion	1 February 2007
Sites	1 location across United States

Drugs / interventions tested

• Cyclophosphamide and Topotecan — full drug profile →

Conditions studied

• Solid Tumors — all drugs for Solid Tumors →

Sponsor

Children's Medical Center Dallas

Who can join

Under 21, any sex, with Solid 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.

• Radiographic imaging
  Time frame: Every 2 cycles

Sponsor's own description

The purposes of this study include:

* Determination of the change in clearance of topotecan and topotecan lactone between day 1 and day 14 for patients receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days.
* Determination of the correlation between the activity of CYP3A4, as measured by the 14C- Erythromycin Breath Test (ERMBT), and topotecan/topotecan lactone clearance for patients receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days.
* Determination of the response rate to oral cyclophosphamide and oral topotecan in recurrent and/or refractory pediatric solid tumors.
* Obtain additional safety data for the chemotherapy regimen, p.o. topotecan and p.o. cyclophosphamide x 14 days.
* Report the frequency of severe toxicities associated with the level of CYP3A4 activity, as measured by the ERMBT, for patients receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.