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Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer Clinical research trials and Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer  Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer
For Condition: paranasal sinus and nasal cavity cancer,primary central nervous system lymphoma,adult brain tumor
Status: Recruiting
Sponsor(s): Herbert Irving Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy combined with peripheral stem cell transplantation in treating patients who have central nervous system cancer.
Details: OBJECTIVES: - Determine the response rate in patients with central nervous system malignancies treated with intensive chemotherapy supported by autologous peripheral blood stem cell transplantation following surgical resection and/or radiotherapy. - Determine the disease-free survival and overall survival of this patient population treated with these regimens. - Determine the toxicity of this high-dose chemotherapy regimen in these patients. - Assess the quality of life of these patients following these treatment regimens. OUTLINE: Patients with anaplastic astrocytoma, esthesioneuroblastoma, germ cell tumor, or primary neuroectodermal tumor undergo initial surgical resection followed by conventional or stereotactic radiotherapy. Patients with germ cell or primary neuroectodermal tumors also receive 4 courses of standard chemotherapy comprising cyclophosphamide, etoposide, and cisplatin prior to high-dose chemotherapy. All patients undergo peripheral blood stem cell or bone marrow harvest followed by high-dose chemotherapy consolidation. Patients receive thiotepa IV 3 times daily on days -7 to -3, carmustine IV over 1 hour on days -6 to -3, and etoposide IV over 5 hours on days -6 to -3. Patients then undergo transplantation on day 0. Filgrastim (G-CSF) is administered concurrently with stem cell harvesting and transplantation. Patients with recurrent oligodendroglioma or CNS lymphoma who have not received radiotherapy at diagnosis undergo conventional radiotherapy 6 weeks after completion of high-dose chemotherapy. Patients are followed every 2-3 months for 1 year and then annually for 5 years. Quality of life is assessed at follow-up. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignant tumors - Anaplastic astrocytoma - Oligodendroglioma - Germ cell tumor - Medulloblastoma - Primary neuroectodermal tumor - Esthesioneuroblastoma - CNS lymphoma (primary or systemic disease) - Multifocal intracranial disease allowed - No extraneural metastases (except controlled systemic lymphoma) - Pretreatment considerations based on tumor type - Anaplastic astrocytoma: - Recurrent disease - Any treatment at diagnosis allowed (carmustine dose limited to 480 mg/m2) - Chemotherapy not required at recurrence - Oligodendroglioma: - Disease response (at least minor) to conventional chemotherapy OR - Recurrent disease - Esthesioneuroblastoma: - Attempted complete surgical resection - Disease progression after radiotherapy - Response to chemotherapy regimen comprising cyclophosphamide, etoposide, and cisplatin - CNS lymphoma: - Disease refractory to methotrexate OR - Failure after initial treatment with methotrexate OR - Considered at high risk for disease relapse despite initial response - Radiographic or pathological confirmation of recurrent disease required - Not eligible for other high priority national or institutional clinical studies PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG or Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Creatinine less than 1.5 times normal Cardiovascular: - LVEF at least 45% Pulmonary: - DLCO at least 60% predicted OR - Approval of pulmonologist Other: - Not pregnant or nursing - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - No other concurrent chemotherapy Endocrine therapy: - No concurrent anticancer hormonal therapy - No concurrent steroids as antiemetics Radiotherapy: - See Disease Characteristics Surgery: - See Disease Characteristics Other: - No concurrent barbiturates or acetaminophen - Participation in other concurrent supportive care or gene therapy trials allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesHesdorffer, Study Chair, Columbia University
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Charles Hesdorffer 212-305-4907
Additional Information:
Study ID Numbers: CDR0000068360; NCI-G00-1881,CPMC-IRB-8445,CPMC-CAMP-004A
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007982
Other Paranasal Sinus And Nasal Cavity Cancer Studies:
1. Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
2. Temozolomide in Treating Patients With Progressive Low-Grade Glioma
3. Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
4. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors
5. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
Related Studies:
Other paranasal sinus and nasal cavity cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer
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