Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer
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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 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the effectiveness of induction paclitaxel and cyclophosphamide followed by autologous tumor cell vaccine and sargramostim (GM-CSF) followed by high-dose chemotherapy with cisplatin, cyclophosphamide, and carmustine, autologous bone marrow or peripheral blood stem cell transplantation, and interleukin-2 in patients with recurrent or refractory primary high-grade brain tumors.
- Determine the safety and toxicity of this regimen in these patients.
- Determine if a specific quantitative cellular response can be elicited in patients treated with this regimen.
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
- Tumor must be surgically accessible
Bidimensionally measurable disease by clinical exam, CT scan, or x-ray
- Disease must be outside a previously irradiated field or have progressed or developed after radiotherapy
- Previously treated metastatic bony lesions are not considered measurable
- No previously irradiated metastatic disease site unless no response or clear progression on imaging
PATIENT CHARACTERISTICS:
Age:
- 65 and under
Performance status:
- CALGB 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Liver function less than 2.5 times normal unless due to disease
- No active hepatitis B or C
Renal:
- Creatinine less than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- Left ventricular ejection fraction greater than 50% by MUGA or 2-D echocardiogram
- Electrocardiogram normal
Pulmonary:
- FEV1 and DLCO greater than 50% predicted OR
- Clearance by pulmonologist
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No serious underlying co-morbid disease or other medical or psychiatric factor that would preclude study
- Able to be weaned off steroids after surgery
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Recovered from prior conventional chemotherapy
Endocrine therapy:
- No concurrent steroid therapy for mass effect
Radiotherapy:
- See Disease Characteristics
- Recovered from prior conventional radiotherapy
Surgery:
- See Disease Characteristics
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
Additional Information:
No publications provided
| Responsible Party: | Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00014573 History of Changes |
| Other Study ID Numbers: | CDR0000068559, P30CA022453, WSU-D-1654, WSU-07-92-98-P04-FB, NCI-G01-1937 |
| Study First Received: | April 10, 2001 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
|
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 |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases Carmustine Cyclophosphamide Aldesleukin Cisplatin Paclitaxel Lenograstim Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Myeloablative Agonists Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic Adjuvants, Immunologic Anti-HIV Agents Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on May 16, 2013