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Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma Clinical research trials and Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma. Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma clinical trial. Subjects frequently obtain the most expert healthcare possible for their Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma  Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma
Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma
For Condition: childhood cerebral astrocytoma and malignant glioma,childhood ependymoma,adult brain tumor,Childhood Oligodendroglioma,childhood cerebellar astrocytoma,childhood 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 or bone marrow 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 thiotepa followed by peripheral stem cell or bone marrow transplantation in treating patients who have malignantglioma.
Details: OBJECTIVES: - Determine the response rate, disease-free interval, and overall survival of patients with malignant glioma treated with high-dose thiotepa followed by autologous peripheral blood stem cell transplantation. - Determine the toxicity of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. - Determine whether this drug enters the cerebrospinal fluid of these patients. OUTLINE: Following a course of induction chemotherapy with cyclophosphamide IV over 4 hours, patients receive filgrastim (G-CSF) daily until the completion of peripheral blood stem cell (PBSC) harvesting. PBSCs are collected over 3-5 days. Patients who do not mobilize sufficient cells undergo bone marrow harvest. Patients receive high-dose thiotepa IV over 5 hours on day -2. PBSCs or bone marrow are reinfused on day 0. Patients receive sargramostim (GM-CSF) subcutaneously daily beginning on day 0 and continuing until blood counts recover. Treatment repeats every 2-3 weeks for a total of 1-4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at every course, then monthly for 6 months, and then every 2 months thereafter. Patients are followed monthly for 6 months and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 5-40 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignant glioma - Primary or recurrent glioblastoma multiforme (including gliosarcoma) following surgery and radiotherapy or prior conventional chemotherapy (e.g., carmustine or procarbazine, vincristine, and lomustine) - Recurrent or refractory anaplastic astrocytoma following any prior therapy (must be chemoresistant) - Recurrent or refractory ependymoma or primitive neuroectodermal tumor (PNET) following any prior therapy - Recurrent or refractory oligodendroglioma or oligoastrocytoma following any prior therapy (must be chemoresistant) - Evaluable disease on gadolinium-enhanced MRI - Ineligible for other high priority national or institutional study (e.g., protocol CAMP-004) PATIENT CHARACTERISTICS: Age: - Any age Performance status: - ECOG 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% by MUGA Pulmonary: - DLCO at least 60% of predicted OR - Approval by pulmonologist Other: - Not pregnant or nursing - Fertile patients must use effective contraception - 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 - See Surgery Surgery: - See Disease Characteristics - For patients with glioblastoma multiforme, concurrent surgery and/or stereotactic radiosurgery to reduce tumor bulk allowed Other: - No concurrent acetaminophen during chemotherapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesHesdorffer, Study Chair, Columbia University
St. Joseph's Hospital and Medical Center *Recruiting*
Paterson, New Jersey, 07503
United States
Recruiting Arnold Rubin 973-754-2432
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: CDR0000068362; CPMC-CAMP-013,CPMC-IRB-8017,NCI-G00-1883
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008008
Other Childhood Oligodendroglioma Studies:
1. O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
2. Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma
3. Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
4. Tipifarnib in Treating Young Patients With Recurrent, Refractory, or Progressive High-Grade Glioma, Medulloblastoma, Primitive Neuroectodermal Tumor, or Brain Stem Glioma
5. TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma
Related Studies:
Other Childhood Oligodendroglioma Clinical Trials
Other New Jersey Clinical Trials
Other Paterson Clinical Trials
Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma
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