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| Sponsor: | Barbara Ann Karmanos Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00014573 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Vaccines made from a person's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and vaccine therapy followed by bone marrow or peripheral stem cell transplantation and interleukin-2 in treating patients who have recurrent or refractory brain cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: aldesleukin Biological: autologous tumor cell vaccine Biological: filgrastim Biological: sargramostim Biological: therapeutic autologous lymphocytes Drug: carmustine Drug: cisplatin Drug: cyclophosphamide Drug: paclitaxel Procedure: autologous bone marrow transplantation Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Trial Of High Dose Cyclophosphamide, Cisplatin And Carmustine With Stem Cell Reconstitution Followed By Specific Cellular Therapy In Patients With Recurrent Or Refractory Brain Tumors |
| Study Start Date: | August 1998 |
OBJECTIVES:
OUTLINE: After partial surgical resection of tumor, patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and cyclophosphamide IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 3 and continuing until peripheral blood stem cell (PBSC) or bone marrow collection is completed.
After the collection of PBSC or bone marrow, patients receive autologous tumor cell vaccine and sargramostim (GM-CSF) SC once every 2 weeks for up to 5 vaccinations. Two weeks after the last vaccination, patients undergo a second leukapheresis to collect lymphocytes.
After completion of the second leukapheresis, patients receive high-dose chemotherapy comprising cisplatin IV continuously over 24 hours on day -5, cyclophosphamide IV over 1 hour on days -5, -4, and -3, and carmustine IV over 2 hours on day -2. Patients undergo autologous bone marrow or PBSC transplantation on day 0. Patients receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover.
Approximately 12 weeks after bone marrow or PBSC transplantation, patients receive autologous lymphocytes IV over 2-5 hours. Patients also receive interleukin-2 IV once every other day for 10 days.
Patients are followed at 18, 24, 36, 40, and 52 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed active recurrent or refractory primary high-grade brain tumor
Bidimensionally measurable disease by clinical exam, CT scan, or x-ray
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Study Chair: | Esteban Abella, MD | Barbara Ann Karmanos Cancer Institute |
More Information
| Study ID Numbers: | CDR0000068559, WSU-D-1654, WSU-07-92-98-P04-FB, NCI-G01-1937 |
| Study First Received: | April 10, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00014573 History of Changes |
| Health Authority: | United States: Federal Government |
|
childhood infratentorial ependymoma childhood supratentorial ependymoma childhood central nervous system germ cell tumor recurrent adult brain tumor adult brain stem glioma adult medulloblastoma adult glioblastoma childhood high-grade cerebral astrocytoma adult anaplastic astrocytoma childhood choroid plexus tumor childhood grade III meningioma adult anaplastic ependymoma |
adult mixed glioma adult central nervous system germ cell tumor adult ependymoblastoma recurrent childhood brain stem glioma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma adult choroid plexus tumor recurrent childhood ependymoma adult grade III meningioma adult giant cell glioblastoma adult gliosarcoma |
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Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Central Nervous System Neoplasms Neoplasms by Site Anti-Retroviral Agents Cisplatin Therapeutic Uses Alkylating Agents Nervous System Neoplasms Anti-HIV Agents Carmustine |
Nervous System Diseases Mitosis Modulators Antimitotic Agents Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Aldesleukin Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |
