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| Name | Class |
|---|---|
| University of Calgary | OTHER |
| Northwestern University | OTHER |
| Northwestern Memorial Hospital | OTHER |
| Massachusetts General Hospital |
The purpose of this study is to see how effective treatment of high doses of chemotherapy is for your tumor. We will also be looking at the side effects and risks of this treatment.
You will receive very high doses of chemotherapy. High doses of chemotherapy can destroy tumor cells, but it can also destroy normal bone marrow cells. These cells produce white blood cells (which fight infection), red blood cells (which carry oxygen) and platelets (which allow your blood to clot). With too few of these cells there is a serious risk of infection and bleeding.
Therefore, before treatment begins, we will collect some of your own blood cells, called peripheral blood progenitor cells (PBPCs). These cells help create new blood cells. The PBPCs are frozen and saved while you are being treated. Then at the end of treatment, your PBPCs are thawed and given back to you. These healthy PBPCs will replace the blood cells that the high dose chemotherapy destroys and allow your bone marrow to recover and produce blood cells. In a prior study we treated 69 patients in a similar way. More than half were able to avoid or delay brain radiation. This new study will use a different high dose chemotherapy regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | temozolomide followed by high dose busulfan and thiotepa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temozolomide followed by high dose busulfan and thiotepa | Drug | Temozolomide 200mg/m2 PO Days 1-5 recycled every 28 days Day minus -8 thiotepa 250 mg/m2 intravenously Day minus -7 thiotepa 250 mg/m2 intravenously Day minus -6 thiotepa 250 mg/m2 intravenously Day minus -5 busulfan 3.2 mg/kg intravenously over two hours Day minus -4 busulfan 3.2 mg/kg intravenously over two hours Day minus -3 busulfan 3.2 mg/kg intravenously over two hours Day minus -2 rest Day minus -1 rest Day 0 peripheral blood stem cell or bone marrow reinfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Progession Free Survival | To determine the duration of disease control of newly diagnosed pure and mixed anaplastic oligodendrogliomas treated with dose-intensive chemotherapy requiring hematopoietic stem cell support. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Evaluated for Toxicities | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Kaley, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Basking Ridge | New Jersey | United States | |||
| Memorial Sloan Kettering Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28472509 | Derived | Thomas AA, Abrey LE, Terziev R, Raizer J, Martinez NL, Forsyth P, Paleologos N, Matasar M, Sauter CS, Moskowitz C, Nimer SD, DeAngelis LM, Kaley T, Grimm S, Louis DN, Cairncross JG, Panageas KS, Briggs S, Faivre G, Mohile NA, Mehta J, Jonsson P, Chakravarty D, Gao J, Schultz N, Brennan CW, Huse JT, Omuro A. Multicenter phase II study of temozolomide and myeloablative chemotherapy with autologous stem cell transplant for newly diagnosed anaplastic oligodendroglioma. Neuro Oncol. 2017 Oct 1;19(10):1380-1390. doi: 10.1093/neuonc/nox086. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Newly Diagnosed Anaplastic Oligodendroglioma | temozolomide followed by high dose busulfan and thiotepa |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Oct 26, 2018 |
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| OTHER |
| Schering-Plough | INDUSTRY |
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|
| Commack |
| New York |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Newly Diagnosed Anaplastic Oligodendroglioma | temozolomide followed by high dose busulfan and thiotepa |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Progession Free Survival | To determine the duration of disease control of newly diagnosed pure and mixed anaplastic oligodendrogliomas treated with dose-intensive chemotherapy requiring hematopoietic stem cell support. | Posted | Number | 95% Confidence Interval | % of participants without progression | 2 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants Evaluated for Toxicities | Posted | Count of Participants | Participants | up to 2 years |
|
|
|
2 years
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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 | Participants With Newly Diagnosed Anaplastic Oligodendroglioma | temozolomide followed by high dose busulfan and thiotepa | 30 | 60 | 26 | 60 | 57 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal cramping | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bilirubin | Investigations | Systematic Assessment |
| ||
| CNS Hemorrhage | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| CNS Necrosis/cystic progression | Nervous system disorders | Systematic Assessment |
| ||
| Catheter related infection | Infections and infestations | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Delusions | Psychiatric disorders | Systematic Assessment |
| ||
| Derm, skin other | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Gastrointestinal, other | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hematoma | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
| ||
| Infection unk ANC | Infections and infestations | Systematic Assessment |
| ||
| Infection w/out neutropenia | Infections and infestations | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| White blood cells | Investigations | Systematic Assessment |
| ||
| Liver dysfunction/failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Mood alteration/anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Muscle weakness - whole body/general | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neurology, other | Nervous system disorders | Systematic Assessment |
| ||
| Neutrophils/granulocytes (ANC/AGC) | Investigations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Platelets | Investigations | Systematic Assessment |
| ||
| Rash, dequamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Veno-Occlusive Disease | Vascular disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelets | Investigations | Systematic Assessment |
| ||
| Leukocytes | Investigations | Systematic Assessment |
| ||
| Neutrophils | Investigations | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Hemoglobin | Investigations | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Platelets | Investigations | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Edema | General disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Lymphopenia | Investigations | Systematic Assessment |
| ||
| Rash/desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| AST, SGOT | Investigations | Systematic Assessment |
| ||
| Abdominal pain/cramping | Gastrointestinal disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Pain - other | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Kaley, MD | Memorial Sloan Kettering Cancer Center | 212-639-7523 | kaleyt@mskcc.org |
| Sep 29, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| D013852 | Thiotepa |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|