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Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00610571
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : October 25, 2013
Information provided by (Responsible Party):
Katy Peters, Duke University

Brief Summary:


  • 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.

Condition or disease Intervention/treatment Phase
Glioblastoma Gliosarcoma Anaplastic Astrocytoma Drug: Oral Topotecan and Temodar Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas
Study Start Date : April 2004
Actual Primary Completion Date : September 2009
Actual Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: Oral Topotecan and Temodar
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

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.

Other Names:
  • Temodar - Temozolomide
  • Topotecan - Hycamtin

Primary Outcome Measures :
  1. maximum tolerated dose [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Safety & efficacy [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00610571

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United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Katy Peters
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Principal Investigator: Katherine B Peters, MD, PhD Duke Health
Additional Information:
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Responsible Party: Katy Peters, Assistant Professor, Duke University Identifier: NCT00610571    
Other Study ID Numbers: Pro00003970
5487 ( Other Identifier: Old Duke IRB number )
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013
Keywords provided by Katy Peters, Duke University:
Malignant Gliomas
Brain tumor
Anaplastic astrocytoma
Glioblastoma Multiform
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors