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Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

Primary Purpose

Glioblastoma, Gliosarcoma, Anaplastic Astrocytoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Oral Topotecan and Temodar

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Temodar, Temozolomide, Topotecan, Hycamtin, Malignant Gliomas, Brain tumor, Anaplastic astrocytoma, AA, GBM, Glioblastoma Multiform, Gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Topotecan and Temodar

Arm Description

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

Outcomes

Primary Outcome Measures

maximum tolerated dose

Secondary Outcome Measures

Safety & efficacy

Full Information

NCT ID

NCT00610571

First Posted

January 28, 2008

Last Updated

October 23, 2013

Sponsor

Katy Peters

Collaborators

GlaxoSmithKline, Schering-Plough

1. Study Identification

Unique Protocol Identification Number

NCT00610571

Brief Title

Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

Official Title

Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Katy Peters

Collaborators

GlaxoSmithKline, Schering-Plough

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma, Gliosarcoma, Anaplastic Astrocytoma

Keywords

Temodar, Temozolomide, Topotecan, Hycamtin, Malignant Gliomas, Brain tumor, Anaplastic astrocytoma, AA, GBM, Glioblastoma Multiform, Gliosarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Topotecan and Temodar

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Oral Topotecan and Temodar

Other Intervention Name(s)

Temodar - Temozolomide, Topotecan - Hycamtin

Intervention Description

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.

Primary Outcome Measure Information:

Title

maximum tolerated dose

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Safety & efficacy

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katherine B Peters, MD, PhD

Organizational Affiliation

Duke Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Health System

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.cancer.duke.edu/btc/

Description

The Preston Robert Tisch Brain Tumor Center at DUKE

Learn more about this trial

Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

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