NCT00610571

Brief Summary

Objectives:

  • To determine the maximum tolerated dose of oral topotecan when administered with Temodar to patients with malignant glioma
  • To characterize any toxicity associated with the combination oral topotecan and Temodar.
  • To observe patients for clinical antitumor response when treated with oral topotecan and Temodar.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_1

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

April 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

5.4 years

First QC Date

January 28, 2008

Last Update Submit

October 23, 2013

Conditions

GlioblastomaGliosarcomaAnaplastic Astrocytoma

Keywords

TemodarTemozolomideTopotecanHycamtinMalignant GliomasBrain tumorAnaplastic astrocytomaAAGBMGlioblastoma MultiformGliosarcoma

Outcome Measures

Primary Outcomes (1)

  • maximum tolerated dose

    6 months

Secondary Outcomes (1)

  • Safety & efficacy

    6 months

Study Arms (1)

Oral Topotecan and Temodar

EXPERIMENTAL

Two separate strata to accrue independently. Stratum 1: Patients taking receiving Dilantin, Tegretol, Trileptal or Phenobarbital. Stratum 2: Patients on anti-convulsants other than Dilantin, Tegretol, Trileptal or Phenobarbital or patients not on any anti-convulsants

Drug: Oral Topotecan and Temodar

Interventions

Oral Topotecan and TemodarDRUG

Temozolomide is taken by mouth once day, every day for 5 consecutive days at dose of 200 mg/m2/day. Oral Topotecan will be taken daily for 5 consecutive days beginning 12-24 hrs after 1st dose of Temozolomide. Dose escalation of Oral Topotecan will be carried out in cohorts of 3 new subjects beginning w dose level 1 @ 0.75 mg/m2/dose.

Also known as: Temodar - Temozolomide, Topotecan - Hycamtin
Oral Topotecan and Temodar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histology: GBM, AA or grade 3 or greater WHO astrocytic, oligodendroglial or mixed glial tumors which were initially diagnosed by histologic exam of biopsy/resection
  • Age: \> or equal to 18 years
  • Performance Status: Karnofsky Performance Status \> or equal to 60% at study entry.
  • Renal Function: Serum creatinine \< 1.5 mg/dl or creatinine clearance \> 60 ml/dL.
  • Hematologic Status: The following baseline studies will be required before entry: total granulocyte count \> or equal to 1000/microliter; platelet count \> 100,000/microliter
  • Hepatic Function: Serum SGOT \& total bilirubin \< or equal to 2.5 times ULN.
  • Note: All lab parameters must have been obtained within 1 week of registration
  • Consent: Signed informed consent, approved by IRB, will be obtained prior to initiating treatment
  • Corticosteroids: For patients currently on corticosteroids, patients should be on stable dose for 1 week prior to study entry, if clinically possible.
  • Prior Therapy: Interval of at least 2 weeks between prior surgical resection or prior radiotherapy (XRT) or 1 week from completion of chemotherapy and all toxicities are \< or equal to grade 1 \& enrollment on this protocol unless there is unequivocal evidence of progressive disease.
  • Patients with Reproductive Potential: Patients must agree to practice effective birth control measures while on study and for 2 months after completing therapy

You may not qualify if:

  • Pregnant or breast feeding women or women or men with reproductive potential not practicing adequate contraception. This therapy may be associated with potential toxicity to the fetus or child that exceeds minimum risks necessary to meet health needs of mother
  • Active infection requiring intravenous antibiotics
  • Prior failure with either topotecan or temozolomide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Related Links

MeSH Terms

Conditions

GlioblastomaGliosarcomaAstrocytomaGliomaBrain Neoplasms

Interventions

TopotecanTemozolomide

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Katherine B Peters, MD, PhD

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 8, 2008

Study Start

April 1, 2004

Primary Completion

September 1, 2009

Study Completion

April 1, 2012

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations

US(1)