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Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors 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 Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors Clinical research trials and Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors 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 Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors. Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors 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 Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors clinical trial. Subjects frequently obtain the most expert healthcare possible for their Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors 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 > "P" Clinical Trials Conditions > Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors  Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
For Condition: unspecified childhood solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, use different ways to stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: Phase I trial to study the effectiveness of pemetrexed disodium in treating young patients who have recurrentsolid tumors.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of pemetrexed disodium in children and adolescents with refractory solid tumors. - Determine the dose-limiting toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. Secondary - Determine, preliminarily, the antitumor activity of this drug in these patients. - Correlate the presence of the C677T polymorphism of the methylenetetrahydrolate reductase gene, the presence of a polymorphism in the enhancer region of the thymidylate synthase (TS) gene promoter (2R and 3R tandem repeats), the presence of a polymorphism within one of those repeats, and the presence of a functional polymorphism in the 3’-untranslated region with toxicity in patients treated with this drug. - Correlate homocysteine and methylmalonic acid levels at study entry with toxicity in patients treated with this drug. - Correlate various gene expression profiles with response in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of pemetrexed disodium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor for which there is no known curative therapy or therapy that is known to prolong survival with acceptable quality of life - Histologic requirement waived for intrinsic brain stem tumors - No pleural effusion or ascites - Neurological deficits from CNS tumors must have been relatively stable for at least 1 week prior to study entry PATIENT CHARACTERISTICS: Age - 1 to 21 Performance status - Karnofsky 50-100% (over 10 years of age) - Lansky 50-100% (10 years of age and under) Life expectancy - At least 8 weeks Hematopoietic - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 (transfusion independent) - Hemoglobin at least 8.0 g/dL (transfusion allowed) Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT no greater than 2.5 times ULN - Albumin at least 2 g/dL Renal - Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR - Creatinine based on age as follows: - No greater than 0.8 mg/dL (age 5 and under) - No greater than 1.0 mg/dL (age 6 to 10) - No greater than 1.2 mg/dL (age 11 to 15) - No greater than 1.5 mg/dL (age 16 and over) Pulmonary - No evidence of dyspnea at rest - No exercise intolerance Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No evidence of Approved-not yet active graft-versus-host disease - No uncontrolled infection - Seizure disorder allowed provided it is well-controlled with anticonvulsants - CNS toxicity no greater than grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy - Recovered from prior immunotherapy - At least 7 days since prior antineoplastic biologic therapy - At least 6 months since prior allogeneic stem cell transplantation - More than 1 week since prior growth factors - No concurrent biologic therapy - No concurrent immunotherapy - No concurrent prophylactic growth factor support during course 1 Chemotherapy - No prior pemetrexed disodium - More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered - No other concurrent chemotherapy Endocrine therapy - Concurrent dexamethasone for CNS tumors allowed provided dose has been stable or decreasing for at least 1 week prior to study entry Radiotherapy - Recovered from all prior radiotherapy - At least 2 weeks since prior local palliative radiotherapy - At least 6 months since prior craniospinal radiotherapy - At least 6 months since prior radiotherapy to 50% or more of the pelvis - At least 6 weeks since prior substantial bone marrow radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - No trimethoprim or sulfa within 2 days before and after study drug administration - No concurrent nonsteroidal anti-inflammatory agents (e.g., ibuprofen and aspirin) - No other concurrent anticancer or investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LindaStork, , Oregon Health and Science University
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Regina Jakacki 412-692-5055
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting John Holcenberg 206-987-2106
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4215
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Holcombe Grier 617-632-3971
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Peter Adamson 215-590-5448
Hopital Sainte Justine *Recruiting*
Montreal, Quebec, H3T 1C5
Canada
Recruiting Albert Moghrabi 514-345-4969
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Carola Arndt 507-284-4822
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Brenda Weigel 612-626-8484
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2916
United States
Recruiting Anne Angiolillo 202-884-2800
Doernbecher Children's Hospital at Oregon Health & Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting H. Nicholson 503-494-1543
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Ronald Dubowy 315-464-5294
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Mitchell Cairo 212-305-8316
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-2899
United States
Recruiting Robert Wells 513-636-4200
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting James Croop 317-278-4822
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting Dale Pullen 601-984-5220
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9063
United States
Recruiting Naomi Winick 214-648-3074
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Wayne Furman 901-495-3300
Lucile Packard Children's Hospital at Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Gary Houten Dahl 650-497-8238
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Sylvain Baruchel 416-813-7795
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027-0700
United States
Recruiting Paul Gaynon 323-669-2163
Additional Information:
Study ID Numbers: CDR0000334572; COG-ADVL0311
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070473
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
2. Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
3. Irinotecan in Treating Children With Refractory or Progressive Solid Tumors
4. Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment
5. Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other New York Clinical Trials
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Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
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