|
Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma Clinical research trials and Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma. Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma clinical trial. Participants frequently get the best healthcare available for their Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma  Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
For Condition: leptomeningeal metastases
Status: Completed
Sponsor(s): Norris Cotton Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma.
Details: OBJECTIVES: - Determine the objective response rate, survival time, and quality of life of patients with leptomeningeal metastases from a solid tumor or lymphoma when treated with oral temozolomide. - Determine adverse events related to this regimen in this patient population. - Measure temozolomide concentrations in CSF and serum and correlate with appropriate pharmacodynamic parameters (e.g., response) in these patients. OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Courses repeat every 10 weeks in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 2 additional courses after achieving CR. Patients with a CR except for residual radiographic abnormalities that persist unchanged for 2 full courses continue for 4 courses past best response. Quality of life is assessed at baseline, weekly for the first 4 weeks of therapy, and then monthly thereafter. PROJECTED ACCRUAL: A total of 14-24 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Documented leptomeningeal metastases - Carcinomatous meningitis that is previously untreated or failed prior therapy OR - Lymphomatous meningitis - Newly diagnosed lymphoma (meningeal plus other sites at initial diagnosis) not allowed - Must meet 1 of the following criteria: - Relapsed after prior standard therapy for leptomeningeal metastases - Untreated lymphomatous meningitis eligible if one of the following are true: - Over 60 years of age - Not likely to have significant potential for cure of systemic disease (i.e., less than 30% 5-year survival estimate) - Leptomeningeal metastases diagnosed by at least 1 of the following: - Positive CSF cytology - Negative CSF cytology with compatible clinical syndrome plus MRI and/or CSF abnormalities - MRI compatible with leptomeningeal metastases to show abnormal FLAIR sequence signal in the subarachnoid space plus evidence of pial, arachnoid, or dural enhancement after administration of motexafin gadolinium in the absence of clinical findings to suggest infectious meningitis - Systemic disease that is responding or stable on current therapy not eligible if discontinuing therapy would be deleterious PATIENT CHARACTERISTICS: Age: - See Disease Characteristics - Over 18 Performance status: - Karnofsky 60-100% Life expectancy: - At least 6 weeks Hematopoietic: - Absolute neutrophil count greater than 1,500/mm3 - Platelet count greater than 100,000/mm3 Hepatic: - Not specified Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No congestive heart failure - No unstable angina Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No contraindication to diagnostic sampling of CSF via lumbar puncture or reservoir - No medical conditions that would interfere with absorption of oral medication (e.g., malabsorption, obstruction, or frequent vomiting) - No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Prior neuroaxis chemotherapy (lumbar puncture, reservoir, or systemic) allowed - No other concurrent chemotherapy for other sites of disease Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to areas of measurable meningeal disease unless there is clear radiographic progression in these areas - No prior radiotherapy to greater than 30% of bone marrow - Prior radiotherapy to the neuroaxis allowed - No concurrent radiotherapy for other sites of disease or for progressive disease Surgery: - Not specified Other: - Recovered from any prior recent therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasDavis, Study Chair, Norris Cotton Cancer Center
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Additional Information:
Study ID Numbers: CDR0000067814; DMS-9812,NCI-G00-1782
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005812
Other Leptomeningeal Metastases Studies:
1. Gemcitabine in Treating Neoplastic Meningitis in Patients With Leukemia, Lymphoma, or Solid Tumors
2. Intrathecal Gemcitabine in Treating Patients With Cancer and Neoplastic Meningitis
3. Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors
4. Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors
5. Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
Related Studies:
Other leptomeningeal metastases Clinical Trials
Other New Hampshire Clinical Trials
Other Lebanon Clinical Trials
Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
|
|
|
|
|
|
|
|
