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New treatment option for Glioblastoma
Official title A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT03970447
What this study is testing
What is Temozolomide?
Temozolomide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for glioblastoma.
Also referred to as Temodar, Temodal.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. All institutions are enrolling Newly Diagnosed participants.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Newly Diagnosed
- Age ≥ 18 years.
- Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH)...
- Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization.
- Availability of tumor tissue representative of GBM from definitive surgery or biopsy. Recurrent
You likely can't join if
- Received any prior treatment for glioma including: a. Prior prolifeprospan 20 with carmustine wafer. b. Prior intracerebral, intratumoral, or...
- Extensive leptomeningeal disease.
- QTc \> 470 msec
- History of another malignancy in the previous 2 years, with a disease-free interval of \< 2 years. Patients with prior history of in situ cancer or...
- Early disease progression prior to 3 months (12 weeks) from the completion of RT.
- More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of temozolomide (TMZ) with an...
See the full eligibility criteria
- Newly Diagnosed
- Age ≥ 18 years.
- Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) established following either a surgical resection or biopsy. An MRI scan...
- Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization.
- Availability of tumor tissue representative of GBM from definitive surgery or biopsy. Recurrent
- Age ≥ 18 years.
- Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) at first or second recurrence after initial standard, control or...
- Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.
- Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression.
- Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization.
- Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed. Newly Diagnosed
- Received any prior treatment for glioma including: a. Prior prolifeprospan 20 with carmustine wafer. b. Prior intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent. c. Prior radiation treatment for GBM or...
- Extensive leptomeningeal disease.
- QTc \> 470 msec
- History of another malignancy in the previous 2 years, with a disease-free interval of \< 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Recurrent Exclusion...
- Early disease progression prior to 3 months (12 weeks) from the completion of RT.
- More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of temozolomide (TMZ) with an experimental agent, is considered one line of chemotherapy.)
- Received any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other vascular endothelial growth factor (VEGF) or VEGF receptor-mediated targeted agent.
- Any prior treatment with prolifeprospan 20 with carmustine wafer.
- Any prior treatment with an intracerebral agent.
- Receiving additional, concurrent, active therapy for GBM outside of the trial
- Extensive leptomeningeal disease.
- QTc \> 470 msec
- History of another malignancy in the previous 2 years, with a disease-free interval of \< 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Jackson, Mississippi, United States
- St Louis, Missouri, United States
- New York, New York, United States
+ 34 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; La Jolla, California, United States; Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; Stanford, California, United States and 48 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.