Trial | NCT00610571  Report issue

Title

Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas
Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    62
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.
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.
Study Started
Apr 30
2004
Primary Completion
Sep 30
2009
Study Completion
Apr 30
2012
Last Update
Oct 25
2013
Estimate

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

Oral Topotecan and Temodar Experimental

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

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
No Results Posted