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Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors Clinical research trials and Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors. Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors clinical trial. Test subjects typically receive the most expert healthcare available for their Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors  Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors
Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors
For Condition: leptomeningeal metastases
Status: Suspended
Sponsor(s): Duke 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. Giving drugs into the thin space between the lining of the spinal cord and brain may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of intrathecal busulfan in treating patients with recurrent, refractory, or metastatic leptomeningeal tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of intrathecal busulfan by a limited escalation dosage schedule in patients with recurrent or refractory leptomeningeal tumors. - Determine the cerebrospinal fluid and serum pharmacokinetics of busulfan administered via intralumbar or intraventricular routes in these patients. OUTLINE: This is dose escalation study. Patients are stratified by age (18 and over vs 17 and under). Cohorts of at least 3 patients receive intrathecal busulfan via intralumbar or intraventricular routes twice a week for 2 weeks (4 treatments). If 1 of 3 patients experiences dose limiting toxicity (DLT) at a dose level, 3 additional patients are entered at the same dose level. If 2 of 3 or 2 of 6 patients experiences DLT, the maximum tolerated dose has been exceeded and 6 patients total are treated at the next lower dose. Any patient with objective or significant clinical response may continue treatment by receiving the same dose once a week for 2 consecutive weeks, once a week every other week for 3 weeks (2 treatments), and then once a month thereafter until disease progression or unacceptable toxicity. Patients are followed every 12 weeks for 1 year or until disease progression. PROJECTED ACCRUAL: There will be 5-20 patients accrued into this study over 1-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed neoplasm that is metastatic in the cerebrospinal fluid or leptomeningeal/subarachnoid space - Cytologic diagnosis of malignancy in the cerebrospinal fluid or neuroimaging evidence of leptomeningeal tumor by MRI - Must be a recurrent or refractory leptomeningeal tumor - Leptomeningeal tumors of leukemia, lymphoma, and all germ cell tumors must have also failed initial treatment or be recurrent - No evidence of obstructive hydrocephalus or complete block of the spinal cerebrospinal fluid pathways on prestudy technetium-99m albumin or In 111 DTPA flow study PATIENT CHARACTERISTICS: Age: - 3 and over Performance status: - Over 10: Karnofsky 60-100% - 10 and under: Lansky 60-100% Life expectancy: - At least 8 weeks Hematopoietic: - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 2.5 mg/dL - SGOT or SGPT less than 1.5 times normal Renal: - BUN less than 30 mg/dL - Creatinine less than 1.5 mg/dL - Calcium within normal limits Neurological: - Stable neurological examination - No rapidly progressing or deteriorating neurological deficits Other: - No active infectious process - Magnesium, phosphorus, potassium, chloride, and bicarbonate within normal limits - Not pregnant or nursing - Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy Chemotherapy: - At least 6 weeks since nitrosoureas or mitomycin - At least 4 weeks since any other chemotherapy - At least 3 weeks since intrathecal chemotherapy - No concurrent intrathecal chemotherapy Endocrine therapy: - For patients on corticosteroids: - At least 1 week on stable dose of corticosteroids Radiotherapy: - At least 3 weeks since prior radiotherapy to the CNS - At least 4 weeks since any other prior radiotherapy - No concurrent radiotherapy to the CNS Surgery: - At least 3 weeks since surgery Other: - No concurrent medication that may interfere with study results (e.g., immunosuppressive agents other than corticosteroids)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HenryFriedman, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000066494; DUMC-000672-02-3R4,DUMC-000672-00-3R2,DUMC-000672-01-3R3,DUMC-0631-99-4RI,DUMC-625-98-4,DUMC-98045,DUMC-FDR001519,NCI-G98-1463
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003462
Other Leptomeningeal Metastases Studies:
1. Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
2. Gemcitabine in Treating Neoplastic Meningitis in Patients With Leukemia, Lymphoma, or Solid Tumors
3. Intrathecal Gemcitabine in Treating Patients With Cancer and Neoplastic Meningitis
4. Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
5. Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors
Related Studies:
Other leptomeningeal metastases Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors
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