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Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors Clinical research trials and Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors medical trials happen in hundreds of localities throughout 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 typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors. Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors clinical trial. Participants frequently obtain the most expert healthcare available for their Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), 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 in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors  Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors
Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors
For Condition: recurrent/refractory childhood Hodgkin's disease,childhood diffuse large cell lymphoma,recurrent childhood lymphoblastic lymphoma,recurrent childhood large cell lymphoma,unspecified childhood solid tumor, protocol specific,recurrent childhood acute lymphoblastic leukemia,recurrent childhood small noncleaved cell lymphoma,leptomeningeal metastases,childhood immunoblastic large cell lymphoma,recurrent childhood acute myeloid leukemia
Status: No longer recruiting
Sponsor(s): SkyePharma ,
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 study the effectiveness of liposomal cytarabine in treating young patients who have recurrent or refractory meningeal leukemia, lymphoma, or solid tumors.
Details: OBJECTIVES: I. Determine the qualitative or quantitative toxic effects and tolerability of liposomal cytarabine (Depofoam encapsulated cytarabine; DTC 101) in pediatric patients with recurrent or refractory meningeal malignancies. II. Define a safe dose of DTC 101 in these patients for future clinical studies. III. Determine the plasma and CSF pharmacokinetics of DTC 101 in these patients. PROTOCOL OUTLINE: This is a dose escalation, multicenter study. Patients are placed in one of three age-related strata: stratum 1, 3 to 21 years of age; stratum 2, at least 2 but less than 3 years of age; stratum 3, at least 1 but less than 2 years of age. Patients receive an induction dose of intrathecal liposomal cytarabine (Depofoam encapsulated cytarabine; DTC 101) administered once every 2 weeks for 2 courses. Patients who have achieved a partial response or received significant clinical benefit with stable disease may receive a third induction dose of DTC 101, 2 weeks following the second dose. In the absence of progressive disease, patients can proceed to consolidation therapy. During consolidation therapy, intrathecal DTC 101 is administered once every 4 weeks for 2 courses, beginning 4 weeks after the last induction dose. Patients experiencing a complete or significant response can proceed to maintenance therapy. Patients receive a maintenance dose of intrathecal DTC 101 once every 8 weeks for a total of 6 doses, beginning 4 weeks after the second consolidation dose. At least 3 patients are evaluated at each dose level. Dose escalation to the next level proceeds when a minimum of 3 patients per cohort has successfully completed induction therapy and been evaluated. Patients will be followed at 1, 2, 3, 6, 9, and 12 months post treatment, until relapse or death. PROJECTED ACCRUAL: A minimum of 12-15 patients will be accrued for each stratum over 18 to 24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven recurrent or refractory leukemia, lymphoma, or other solid tumor that has overt meningeal involvement - Definition of meningeal disease: Leukemia/lymphoma: CSF cell count at least 5/mm3 and evidence of blast cells on cytospin preparation or cytology; Solid tumors: Presence of tumor cells on cytospin preparation or cytology OR evidence of meningeal disease on CT or MRI scan - No bone marrow disease --Prior/Concurrent Therapy-- - Biologic therapy: No acute toxic effects from prior immunotherapy; No prior allogeneic or autologous bone marrow transplantations within 3 months of study - Chemotherapy: No prior systemic CNS directed chemotherapy within 3 weeks of study; No prior nitrosourea within 6 weeks of study; No prior intrathecal chemotherapy within 1 week of study; No acute toxic effects from prior chemotherapy; No prior DTC 101; Concurrent systemic chemotherapy for management of primary cancer allowed; Concurrent dexamethasone with systemic chemotherapy regimen allowed; No concurrent chemotherapy for leptomeningeal disease; No concurrent high dose methotrexate, high dose cytarabine, mercaptopurine, thiotepa, fluorouracil, and topotecan - Endocrine therapy: Concurrent prednisone therapy with systemic chemotherapy allowed - Radiotherapy: No prior craniospinal irradiation within 8 weeks of study; No acute toxic effects from prior radiotherapy; Concurrent local radiation therapy allowed; No concurrent whole brain or craniospinal radiotherapy - Surgery: Not specified - Other: At least 2 weeks since investigational drugs and recovered; No other concurrent investigational drugs; Concurrent antibiotic therapy allowed --Patient Characteristics-- - Age: 1 to 21 - Performance Status: ECOG 0-2 - Life Expectancy: At least 8 weeks - Hematopoietic: Platelet count greater than 40,000/mm3 - Hepatic: Bilirubin less than 2.0 mg/dL; ALT less than 5 times upper limit of normal - Renal: Creatinine less than 1.5 mg/dL - Other: Not pregnant or nursing; Negative pregnancy test; Effective contraceptive method used by fertile patients; No uncontrolled illness or infection (except for HIV positive patients); No obstructive hydrocephalus or compartmentalization of the CSF flow
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnGait, Study Chair, SkyePharma
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235-8897
United States
Texas Children's Cancer Center
Houston, Texas, 77030-2399
United States
Alberta Children's Hospital
Calgary, Alberta, T2T 5C7
Canada
Additional Information:
Study ID Numbers: CDR0000065754; SKYEPHARMA-96-002,NCI-V97-1336,DTC-96-002
Study Start Date: February 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003073
Other Childhood Immunoblastic Large Cell Lymphoma Studies:
1. Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
2. Genetic Study of Late-Occurring Complications in Childhood Cancer Survivors
3. Bortezomib in Treating Children With Advanced Solid Tumors
4. Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
5. Oxaliplatin in Treating Children With Advanced Solid Tumors
Related Studies:
Other childhood immunoblastic large cell lymphoma Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors
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