Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
New York University School of Medicine National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025558 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining temozolomide, thiotepa, and carboplatin followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have brain cancer.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: carboplatin Drug: filgrastim Drug: temozolomide Drug: thiotepa Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Dose Escalation of Temozolomide in Combination With Thiotepa and Carboplatin With Autologous Stem Cell Rescue in Patients With Malignant Brain Tumors With Minimal Residual Disease |
Study Start Date: | October 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of temozolomide.
Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily for 3 consecutive days. After the third dose of G-CSF, patients undergo leukapheresis to collect peripheral blood stem cells (PBSC). Patients who do not have adequate PBSC may undergo bone marrow harvest.
Patients then receive oral temozolomide every 12 hours on days -10 to -6 and thiotepa IV over 3 hours and carboplatin IV over 4 hours on days -5 to -3.
PBSC or bone marrow are reinfused on day 0. Beginning on day 1, patients receive G-CSF SC or IV until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at day 42, at 3 months, every 3 months for 2 years, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study.
Ages Eligible for Study: | 1 Year to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following malignant brain tumors:
Recurrent disease or resistant to conventional therapy (e.g., surgery, radiotherapy, or standard chemotherapy)
Newly diagnosed malignant glioma with minimal residual disease after prior radiotherapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New York | |
NYU Cancer Institute at New York University Medical Center | |
New York, New York, United States, 10016 | |
United States, Ohio | |
Columbus Children's Hospital | |
Columbus, Ohio, United States, 43205-2696 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
Australia, Western Australia | |
Princess Margaret Hospital for Children | |
Perth, Western Australia, Australia, 6001 |
Study Chair: | Sharon L. Gardner, MD | New York University School of Medicine |
Study ID Numbers: | CDR0000068973, NYU-0006H, NCI-G01-2022 |
Study First Received: | October 11, 2001 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00025558 |
Health Authority: | United States: Federal Government |
childhood central nervous system germ cell tumor recurrent adult brain tumor adult medulloblastoma adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult mixed glioma adult central nervous system germ cell tumor |
adult pineoblastoma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood medulloblastoma recurrent childhood ependymoma adult giant cell glioblastoma adult gliosarcoma adult anaplastic ependymoma adult supratentorial primitive neuroectodermal tumor (PNET) |
Neoplasm, Residual Glioblastoma Neuroectodermal Tumors, Primitive Astrocytoma Carboplatin Central Nervous System Neoplasms Temozolomide Recurrence Ependymoma |
Thiotepa Brain Neoplasms Neuroectodermal Tumors Medulloblastoma Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Immunosuppressive Agents Pharmacologic Actions Neoplasms |
Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Alkylating Agents |