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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00065863 | Other Identifier | Johns Hopkins University School of Medicine |
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To evaluate the safety and effectiveness of low dose rate radiation therapy plus temozolomide. This will be in patients with High Grade Glioma (to only include Anaplastic Astrocytoma or Glioblastoma Multiforme) who have previously been treated with surgery followed by radiation surgical resection followed by adjuvant radiation therapy plus temozolomide.
In vitro and in vivo studies have suggested that low dose fractionated radiation therapy (LDFRT) may be used to potentiate full dose chemotherapy, decreasing the development of resistance found with standard doses of radiation and chemotherapy. This is a nonrandomized, open label, single institution phase II trial with a safety run-in to evaluate the safety and efficacy of LDFRT plus temozolomide in patients with High Grade Glioma (to only include Anaplastic Astrocytoma or Glioblastoma Multiforme) previously treated with surgical resection followed by adjuvant radiation therapy plus temozolomide. The primary objective of the phase II study is to estimate response rate in patients treated with twice daily fractions of low dose radiation plus temozolomide chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temozolomide with Low Dose Fractionated Radiation Therapy | Experimental | All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression. All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If > 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below. Otherwise, following a 1 month waiting period after the first cycle of adjuvant LDFRT plus temozolomide for the first cohort of patients, the phase 2 study will open for full accrual. Patients will receive radiation with the first six 28-day cycles of temozolomide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Fractionated Radiation Therapy (LDFRT) | Radiation | All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If > 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below. |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | To estimate the response rate to salvage temozolomide plus LDFRT. | 3, 6 and 12 month follow-up after therapy has been completed |
| Overall Survival Rate | Overall survival rate is calculated as the median number of months that patients were alive for the cohort | up to 12 months after completion of temozolomide (48 weeks of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival Rate | Progression free survival rate is calculated as the median number of months for the cohort until patient's disease worsened/progressed | up to 12 months after completion of temozolomide (48 weeks of treatment) |
| Number of Patients With Hematologic Toxicities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Redmond, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States | ||
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
1 patient enrolled in the study and then chose to withdraw prior to assignment/treatment. No data was collected for that participant.
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| ID | Title | Description |
|---|---|---|
| FG000 | Temozolomide With Low Dose Fractionated Radiation Therapy | All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression. All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If > 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below. Otherwise, following a 1 month waiting period after the first cycle of adjuvant LDFRT plus temozolomide for the first cohort of patients, the phase 2 study will open for full accrual. Patients will receive radiation with the first six 28-day cycles of temozolomide. Low Dose Fractionated Radiation Therapy (LDFRT): All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If > 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below. Temozolomide: All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Temozolomide With Low Dose Fractionated Radiation Therapy | All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression. All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If > 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below. Otherwise, following a 1 month waiting period after the first cycle of adjuvant LDFRT plus temozolomide for the first cohort of patients, the phase 2 study will open for full accrual. Patients will receive radiation with the first six 28-day cycles of temozolomide. Low Dose Fractionated Radiation Therapy (LDFRT): All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If > 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below. Temozolomide: All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rate | To estimate the response rate to salvage temozolomide plus LDFRT. | This data was not collected | Posted | 3, 6 and 12 month follow-up after therapy has been completed |
|
Approximately every month from study start until 48 weeks, and then up to 12 months after completion of temozolomide at 3, 6, and 12 months follow up
Other (Not Including Serious) Adverse Events data was not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Temozolomide With Low Dose Fractionated Radiation Therapy | All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression. All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If > 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below. Otherwise, following a 1 month waiting period after the first cycle of adjuvant LDFRT plus temozolomide for the first cohort of patients, the phase 2 study will open for full accrual. Patients will receive radiation with the first six 28-day cycles of temozolomide. Low Dose Fractionated Radiation Therapy (LDFRT): All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If > 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below. Temozolomide: All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade NS |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristin Redmond, MD | Sidney Kimmel Comprehensive Cancer Center @ Johns Hopkins Medicine | 4109556980 | kjanson3@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2022 | May 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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|
| Temozolomide | Drug | All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression. |
|
The number of patients with grade 3+ hematologic toxicities. |
| Approximately every month from study start until 48 weeks, and then up to 12 months after completion of temozolomide at 3, 6, and 12 months follow up |
| Number of Patients With Neurologic Toxicity | The number of patients with reported grade 3+ neurologic toxicities | Approximately every month from study start until 48 weeks, and then up to 12 months after completion of temozolomide at 3, 6, and 12 months follow up |
| Baltimore |
| Maryland |
| 21231 |
| United States |
| Suburban Hospital | Bethesda | Maryland | 20814 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| met baseline criteria per protocol | Count of Participants | Participants |
|
|
| Primary | Overall Survival Rate | Overall survival rate is calculated as the median number of months that patients were alive for the cohort | Posted | Median | 95% Confidence Interval | months | up to 12 months after completion of temozolomide (48 weeks of treatment) |
|
|
|
| Secondary | Progression Free Survival Rate | Progression free survival rate is calculated as the median number of months for the cohort until patient's disease worsened/progressed | Posted | Median | 95% Confidence Interval | months | up to 12 months after completion of temozolomide (48 weeks of treatment) |
|
|
|
| Secondary | Number of Patients With Hematologic Toxicities | The number of patients with grade 3+ hematologic toxicities. | Posted | Count of Participants | Participants | Approximately every month from study start until 48 weeks, and then up to 12 months after completion of temozolomide at 3, 6, and 12 months follow up |
|
|
|
| Secondary | Number of Patients With Neurologic Toxicity | The number of patients with reported grade 3+ neurologic toxicities | Posted | Count of Participants | Participants | Approximately every month from study start until 48 weeks, and then up to 12 months after completion of temozolomide at 3, 6, and 12 months follow up |
|
|
|
| 28 |
| 30 |
| 30 |
| 30 |
| 0 |
| 0 |
|
| Death (Disease Progression) | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 5 |
|
| Death (NOS) | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 5 |
|
| Aphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 4 |
|
| Disease Progression | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 4 |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 4 |
|
| Intraparenchymal Hemorrhage of Brain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 4 |
|
| Lymphocyte Count Decrease | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 4 |
|
| Personality/Behavioral CTC | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment | Grade 4 |
|
| ALT increased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Ambulatory Dysfunction / Inability to Walk | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Aphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Bowel Incontinence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Cognitive Disturbance | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Disease Progression | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| DVT (NOS) | Vascular disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| DVT (RLE) | Vascular disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Hyperglycemia / Elevated Glucose | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Lymphocyte Count Decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Lymphopenia | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Memory Loss | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Motor Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Ocular-Visual | Eye disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Pain (knee) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Pain (lower back) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Pain (NOS) | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Platelet Count Decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Speech Impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Status Epilepticus | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Urinary Incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Weakness (lower extremity) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Weakness (NOS) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |