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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00610571
Other study ID # Pro00003970
Secondary ID 5487
Status Completed
Phase Phase 1
First received January 28, 2008
Last updated October 23, 2013
Start date April 2004
Est. completion date April 2012

Study information

Verified date October 2013
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

Subjects are patients with glioblastoma (GBM), anaplastic astrocytoma (AA) or grade 3 or greater WHO astrocytic, oligodendroglial or mixed glial tumors, which were initially diagnosed by histologic examination of biopsy/resection. Modified classical "3+3" phase I design used to determine maximum tolerated dose of topotecan in combination with Temodar.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date April 2012
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Oral Topotecan and Temodar
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.

Locations

Country Name City State
United States Duke University Health System Durham North Carolina

Sponsors (3)

Lead Sponsor Collaborator
Katy Peters GlaxoSmithKline, Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary maximum tolerated dose 6 months No
Secondary Safety & efficacy 6 months Yes
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