Glioblastoma Clinical Trial
Official title:
Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas
Verified date | October 2013 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | April 2012 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke University Health System | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Katy Peters | GlaxoSmithKline, Schering-Plough |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | maximum tolerated dose | 6 months | No | |
Secondary | Safety & efficacy | 6 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05664243 -
A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT02768389 -
Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma
|
Early Phase 1 | |
Recruiting |
NCT05635734 -
Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT03679754 -
Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102
|
Phase 1 | |
Completed |
NCT01250470 -
Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma
|
Phase 1 | |
Terminated |
NCT03927222 -
Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma
|
Phase 2 | |
Recruiting |
NCT03897491 -
PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT03587038 -
OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
|
Phase 1 | |
Completed |
NCT01922076 -
Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
|
Phase 1 | |
Recruiting |
NCT04391062 -
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT03661723 -
Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT02655601 -
Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001
|
Phase 2 | |
Completed |
NCT02206230 -
Trial of Hypofractionated Radiation Therapy for Glioblastoma
|
Phase 2 | |
Completed |
NCT03493932 -
Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade
|
Phase 1 | |
Terminated |
NCT02709889 -
Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06058988 -
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
|
Phase 2 | |
Completed |
NCT03018288 -
Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)
|
Phase 2 | |
Withdrawn |
NCT03980249 -
Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells
|
Early Phase 1 | |
Not yet recruiting |
NCT04552977 -
A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma
|
Phase 2 | |
Terminated |
NCT02905643 -
Discerning Pseudoprogression vs True Tumor Growth in GBMs
|