Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas
This study is ongoing, but not recruiting participants.
Sponsor:
Katy Peters
Collaborators:
GlaxoSmithKline
Schering-Plough
Information provided by (Responsible Party):
Katy Peters, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00610571
First received: January 28, 2008
Last updated: November 21, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Gliosarcoma 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 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2012 (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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610571
Locations
| United States, North Carolina | |
| Duke University Health System | |
| Durham, North Carolina, United States, 27710 | |
Sponsors and Collaborators
Katy Peters
GlaxoSmithKline
Schering-Plough
Investigators
| 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 |
| ClinicalTrials.gov Identifier: | NCT00610571 History of Changes |
| Other Study ID Numbers: | Pro00003970, 5487 |
| Study First Received: | January 28, 2008 |
| Last Updated: | November 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Duke University:
|
Temodar Temozolomide Topotecan Hycamtin Malignant Gliomas Brain tumor |
Anaplastic astrocytoma AA GBM Glioblastoma Multiform Gliosarcoma |
Additional relevant MeSH terms:
|
Astrocytoma Glioblastoma Glioma Gliosarcoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Temozolomide Topotecan Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013