This study is NOT currently recruiting participants.
Number
001859-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Recruitment has not started Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Pregnant Women;Children;Neonates;Fetuses
Keywords
Radiotherapy; Hypofractionation; Re-irradiation
Recruitment Keyword(s)
None
Condition(s)
Astrocytoma; Glioma; Recurrent Glioblastoma
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Radiation: Radiation Therapy
Supporting Site
National Cancer Institute
Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy.
Objective:
To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.
Eligibility:
People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment.
Design:
Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected.
Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments.
Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit.
Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends.
Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.
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INCLUSION CRITERIA: -Histologic diagnosis of primary glioblastoma (GBM) or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower grade to a grade 4 tumor. -Age >= 18 -KPS >= 70% -Previous tumor irradiation to curative-intent doses. -Radiation dose constraints must be achievable based on assessment with treatment planning CT. -Participants must have adequate organ and marrow function as defined below: --Absolute neutrophil count (ANC) >= 1,000/microL --Platelets >= 100,000/microL --Coagulation: Prothrombin time (PT) / Partial thromboplastin time (PTT) within institutional normal range. --Total and direct bilirubin < 2 x institutional upper limit of normal (ULN) --Aspartate aminotransferase (AST) < 2 x institutional ULN --Alanine transaminase (ALT) < 2 x institutional ULN --Serum creatinine < 1.5 mg/dL --Serum albumin >= 0.75 x institutional normal range -Women of child-bearing potential (WOCBP) and men must agree to use effective contraception (barrier, hormonal, intrauterine device, surgical sterilization, abstinence) from study entry and through 6 months after the last study treatment (restricted period). Men must not freeze or donate sperm within the same period. -Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after the last study treatment. -The ability of a participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: -Recent systemic therapy prior to the initiation of the study therapy as follows: --Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks. --Temozolomide within 2 weeks. --Cytotoxic chemotherapy within 3 weeks. --Any investigational agents within 2 weeks. -Participants who are unable to undergo MRI evaluation or receive gadolinium contrast for any reason. -Any prior therapy after surgical re-resection or biopsy within 2 weeks prior to the initiation of the study therapy. -History of prior therapy with Novacure TTF, Gliadel wafers, or GammaTile therapy. -Positive beta-human chorionic gonadotropin (HCG) pregnancy test performed in females of childbearing potential at screening. -Participants with known or suspected radiation sensitivity syndromes. -Uncontrolled intercurrent illness evaluated by medical history and physical exam that are not stable and would potentially increase the risk to the participant.
-Histologic diagnosis of primary glioblastoma (GBM) or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower grade to a grade 4 tumor.
-Age >= 18
-KPS >= 70%
-Previous tumor irradiation to curative-intent doses.
-Radiation dose constraints must be achievable based on assessment with treatment planning CT.
-Participants must have adequate organ and marrow function as defined below:
--Absolute neutrophil count (ANC) >= 1,000/microL
--Platelets >= 100,000/microL
--Coagulation: Prothrombin time (PT) / Partial thromboplastin time (PTT) within institutional normal range.
--Total and direct bilirubin < 2 x institutional upper limit of normal (ULN)
--Aspartate aminotransferase (AST) < 2 x institutional ULN
--Alanine transaminase (ALT) < 2 x institutional ULN
--Serum creatinine < 1.5 mg/dL
--Serum albumin >= 0.75 x institutional normal range
-Women of child-bearing potential (WOCBP) and men must agree to use effective contraception (barrier, hormonal, intrauterine device, surgical sterilization, abstinence) from study entry and through 6 months after the last study treatment (restricted period). Men must not freeze or donate sperm within the same period.
-Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after the last study treatment.
-The ability of a participant to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
-Recent systemic therapy prior to the initiation of the study therapy as follows:
--Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks.
--Temozolomide within 2 weeks.
--Cytotoxic chemotherapy within 3 weeks.
--Any investigational agents within 2 weeks.
-Participants who are unable to undergo MRI evaluation or receive gadolinium contrast for any reason.
-Any prior therapy after surgical re-resection or biopsy within 2 weeks prior to the initiation of the study therapy.
-History of prior therapy with Novacure TTF, Gliadel wafers, or GammaTile therapy.
-Positive beta-human chorionic gonadotropin (HCG) pregnancy test performed in females of childbearing potential at screening.
-Participants with known or suspected radiation sensitivity syndromes.
-Uncontrolled intercurrent illness evaluated by medical history and physical exam that are not stable and would potentially increase the risk to the participant.
Principal Investigator
Referral Contact
For more information: