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Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

This study has been completed.
Information provided by (Responsible Party):
Katy Peters, Duke University Medical Center Identifier:
First received: January 28, 2008
Last updated: October 23, 2013
Last verified: October 2013


  • 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 Intervention Phase
Anaplastic Astrocytoma
Drug: Oral Topotecan and Temodar
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • maximum tolerated dose [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety & efficacy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: April 2004
Study Completion Date: April 2012
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00610571

United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Katy Peters
Principal Investigator: Katherine B Peters, MD, PhD Duke University Health System
  More Information

Additional Information:
No publications provided

Responsible Party: Katy Peters, Assistant Professor, Duke University Medical Center Identifier: NCT00610571     History of Changes
Other Study ID Numbers: Pro00003970, 5487
Study First Received: January 28, 2008
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Malignant Gliomas
Brain tumor
Anaplastic astrocytoma
Glioblastoma Multiform

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on November 20, 2014