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
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.
Drug: Oral Topotecan and Temodar
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2009 (Final data collection date for primary outcome measure)
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.
- Temodar - Temozolomide
- Topotecan - Hycamtin
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 (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610571
|Duke University Health System
|Durham, North Carolina, United States, 27710 |
||Katherine B Peters, MD, PhD
||Duke University Health System
||Katy Peters, Assistant Professor, Duke University Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 28, 2008
||October 23, 2013
||United States: Food and Drug Administration
Keywords provided by Duke University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 27, 2016
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Topoisomerase I Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating