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Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors Clinical research trials and Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors health trials occur in a lot of 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 potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors. Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors clinical trial. Human subjects often get the best healthcare possible for their Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors  Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
For Condition: leptomeningeal metastases
Status: Completed
Sponsor(s): 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. PURPOSE: Phase I trial to determine the effectiveness of mafosfamide in treating patients who have progressive or refractory meningeal tumors.
Details: OBJECTIVES: - Determine the qualitative and quantitative toxicity of mafosfamide in patients with progressive or refractory meningeal malignancy. - Determine the maximum tolerated dose of this drug in these patients. - Determine the cerebrospinal fluid pharmacokinetics of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive intrathecal mafosfamide over 20 minutes twice weekly for 6 weeks (induction therapy). Patients then receive intrathecal mafosfamide once weekly for 4 weeks (consolidation therapy), twice a month for 4 months, and then monthly thereafter (maintenance therapy) in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of mafosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 3-65 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of leukemia or lymphoma with meningeal involvement defined as cerebrospinal fluid cell count at least 5/mm - AND evidence of blast cells on cytospin preparation or by cytology OR - Diagnosis of other solid tumor with meningeal involvement defined as presence of tumor cells on cytospin preparation or cytology OR presence of measurable meningeal disease on CT or MRI scan - Meningeal malignancy must be progressive or refractory to conventional therapy - Meningeal malignancies secondary to an underlying solid tumor are allowed at initial diagnosis provided there is no conventional therapy - No concurrent bone marrow relapse in leukemia or lymphoma patients - No clinical evidence of obstructive hydrocephalus or compartmentalization of the cerebrospinal fluid flow as documented by a radioisotope indium In 111 or technetium Te 99-DTPA flow study - Patients demonstrating restored flow after focal radiotherapy are allowed PATIENT CHARACTERISTICS: Age: - Over 3 Performance status: - ECOG 0-2 Life expectancy: - At least 8 weeks Hematopoietic: - Not specified Hepatic: - No clinically significant liver function abnormalities Renal: - No clinically significant renal function abnormalities Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study - No clinically significant metabolic parameter abnormalities (e.g., electrolytes, calcium, and phosphorus) - No significant systemic illness (e.g., infection) PRIOR CONCURRENT THERAPY: Biologic therapy: - Recovered from prior immunotherapy Chemotherapy: - At least 1 week since prior intrathecal chemotherapy (2 weeks for cytarabine (liposomal)) and recovered - Concurrent systemic chemotherapy to control systemic or bulk CNS disease allowed with the following exceptions: - No phase I agent - No agent that significantly penetrates the CNS (e.g., high-dose systemic methotrexate (more than 1 g/m^2), high-dose cytarabine (more than 2 g/m^2), IV mercaptopurine, fluorouracil, topotecan, or thiotepa) - No agent known to have serious unpredictable CNS side effects Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - Recovered from prior radiotherapy - At least 8 weeks since prior craniospinal irradiation - Local radiotherapy for symptomatic or bulky CNS disease must be given prior to induction therapy - No concurrent whole brain or craniospinal irradiation - Concurrent partial brain (e.g., base of brain) or limited-field spinal radiotherapy for asymptomatic bulky (radiographically visible) CNS disease allowed - Total CNS radiotherapy dose must not exceed accepted safe tissue tolerances Surgery: - Not specified Other: - At least 1 week since any prior CNS therapy - At least 7 days since prior intrathecal investigational agent - At least 14 days since prior systemic investigational agent - No other concurrent intrathecal or systemic investigational agent - No other concurrent intrathecal or systemic therapy to treat meningeal malignancy - No other concurrent intrathecal therapy or agent that significantly penetrates the blood-brain barrier - No concurrent agent known to have serious unpredictable CNS side effects
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanBlaney, Study Chair, Texas Children's Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Texas Children's Cancer Center
Houston, Texas, 77030-2399
United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Neurological Research Center, Inc.
Bennington, Vermont, 05201
United States
Additional Information:
Study ID Numbers: CDR0000069240; NCI-90-C-0095K,BCM-H-3241
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031928
Other Leptomeningeal Metastases Studies:
1. Gemcitabine in Treating Neoplastic Meningitis in Patients With Leukemia, Lymphoma, or Solid Tumors
2. Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
3. Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors
4. Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain
5. Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
Related Studies:
Other leptomeningeal metastases Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
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