Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborators:
University of Calgary
Northwestern University
Northwestern Memorial Hospital
Massachusetts General Hospital
Schering-Plough
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588523
First received: December 22, 2007
Last updated: February 13, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
CNS Cancer CNS BRAIN |
Drug: temozolomide followed by high dose busulfan and thiotepa |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- 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. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the neurological and systemic toxicities of such treatment. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
temozolomide followed by high dose busulfan and thiotepa
|
Drug: 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
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pathologic evidence of an anaplastic oligodendroglioma. For this study, World Health Organization classification criteria will be used. Central pathology review must take place prior to high-dose therapy but need not occur prior to study entry and induction therapy.
- Pathologic evidence of an anaplastic mixed glioma (i.e. oligoastrocytoma). Again, histopathologic diagnosis will be made using World Health Organization classification criteria. To qualify as a mixed tumor there must be a minimum of 25% oligodendroglial element. Central pathology review must take place prior to high-dose therapy but need not occur in advance of enrollment or induction therapy.
- The diagnostic surgical procedure may have been a complete resection, partial resection, or biopsy.
- Karnofsky performance status > or equal to 60.
- Granulocyte count > or equal to 1.5 X 109/L.
- Platelet count > or equal to 100 X 109/L
- SGOT < than or equal to 2X upper limit of normal.
- Serum creatinine < than or equal to 1.5X upper limit of normal
- Bilirubin < than or equal to 1.5X upper limit of normal
- All patients must sign written informed consent.
Exclusion Criteria:
- Systemic or leptomeningeal metastases (excluding contiguous leptomeninges)
- Prior cranial radiotherapy or systemic chemotherapy
- Other concurrent malignancy (with the exception of cervical carcinoma in situ or basal cell carcinoma of the skin) or serious illness if this would interfere with the prescribed treatment.
- Pregnant or lactating women
- Refusal to use effective contraception
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588523
Locations
| United States, New Jersey | |
| Memoral Sloan Kettering Cancer Center | |
| Basking Ridge, New Jersey, United States | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| Commack, New York, United States | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
University of Calgary
Northwestern University
Northwestern Memorial Hospital
Massachusetts General Hospital
Schering-Plough
Investigators
| Principal Investigator: | Antonio Omuro, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00588523 History of Changes |
| Other Study ID Numbers: | 02-089 |
| Study First Received: | December 22, 2007 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Brain CNS TEMOZOLOMIDE Busulfan Thiotepa |
Additional relevant MeSH terms:
|
Oligodendroglioma Central Nervous System Neoplasms Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Nervous System Neoplasms Neoplasms by Site Nervous System Diseases |
Busulfan Thiotepa Temozolomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists |
ClinicalTrials.gov processed this record on June 18, 2013