Sponsor study identifier
interventional
60
1 country
3
Study Start
September 2002
Actual (reported)Primary Completion
February 2, 2023
Actual (reported)Study Completion
February 2, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2002
Actual (reported)December 22, 2007
Actual (reported)January 8, 2008
Actual (reported)February 2, 2023
Actual (reported)February 2, 2023
Actual (reported)October 27, 2023
Actual (reported)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
Number of Participants Evaluated for Toxicities
up to 2 years
temozolomide followed by high dose busulfan and thiotepa
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
temozolomide followed by high dose busulfan and thiotepa
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordMemorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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.
Thomas Kaley, MD
Memorial Sloan Kettering Cancer Center
60 participants (actual enrollment reported by the registry).
First Submitted
December 22, 2007
First Posted
January 8, 2008
Study Start
September 2002
Actual (reported)Primary Completion
Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent
Contact the study team to confirm eligibility.
February 2, 2023
Actual (reported)Study Completion
February 2, 2023
Actual (reported)Last Updated
October 27, 2023
Results First Posted
October 27, 2023
Record last verified: 2023-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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