NCT00628732

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
Last Updated

January 28, 2009

Status Verified

January 1, 2009

Enrollment Period

2.1 years

First QC Date

February 25, 2008

Last Update Submit

January 27, 2009

Conditions

Solid Tumors

Keywords

CyclophosphamideTopotecanPhase IIChildrenRelapsed solid tumors

Outcome Measures

Primary Outcomes (1)

  • Radiographic imaging

    Every 2 cycles

Study Arms (1)

1

EXPERIMENTAL
Drug: Cyclophosphamide and Topotecan

Interventions

Cyclophosphamide and TopotecanDRUG

Two courses of cyclophosphamide at 50 mg/m2/dose and topotecan 0.8 mg/m2/dose by mouth every morning for 14 days each.

Also known as: Cytoxan and Hycamptin
1

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients must be less than 22 years of age inclusive
  • Tumor histologies: medulloblastoma/PNET, neuroblastoma, sarcomas, and other pediatric solid tumors for which there is no known effective therapy.
  • Patients must have measurable disease, documented by clinical, radiographic, or histologic criteria.
  • Patients must have a performance status of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients \<= 16 years of age.
  • Patients must have a life expectancy of \>= 8 weeks.
  • Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
  • Patients must not be taking the following medications: growth factors, steroids, and CYP3A4 inducers or inhibitors.
  • Patients must have adequate bone marrow, renal, liver function, pulmonary, or central nervous system function.
  • Must be able and willing to participate in all study procedures, including the ERMBT and pharmacokinetic studies.
  • All patients and/or their parents or legal guardians must sign a written informed consent. (11) All institutional, FDA, and NCI requirements for human studies must be met.

You may not qualify if:

  • Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
  • Patients with an uncontrolled infection.
  • Allergy to erythromycin
  • Patients who have previously received either cyclophosphamide or topotecan are eligible for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Interventions

CyclophosphamideTopotecan

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Daniel C Bowers, MD

    UT Southwestern Medical Center of Dallas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 5, 2008

Study Start

January 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

January 28, 2009

Record last verified: 2009-01

Locations

US(1)