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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070473 |
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: This phase I trial is studying the side effects and best dose of pemetrexed disodium in treating young patients with recurrent solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: pemetrexed disodium |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Pemetrexed (LY231514, Alimta) in Children and Adolescents With Recurrent Solid Tumors |
Study Start Date: | October 2003 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine based on age as follows:
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Children's Hospital Los Angeles | |
Los Angeles, California, United States | |
Stanford Cancer Center at Stanford University Medical Center | |
Stanford, California, United States, 94305 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010-2970 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202-5289 | |
United States, Maryland | |
NCI - Pediatric Oncology Branch | |
Bethesda, Maryland, United States | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Minnesota | |
Fairview University Medical Center - University Campus | |
Minneapolis, Minnesota, United States, 55455 | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Mississippi | |
University of Mississippi Medical Center | |
Jackson, Mississippi, United States, 39216-4505 | |
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 | |
SUNY Upstate Medical University Hospital | |
Syracuse, New York, United States, 13210 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229-3039 | |
United States, Oregon | |
Cancer Institute at Oregon Health and Science University | |
Portland, Oregon, United States, 97239-3098 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
Baylor University Medical Center - Houston | |
Houston, Texas, United States | |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
Dallas, Texas, United States, 75390 | |
United States, Washington | |
Children's Hospital and Regional Medical Center - Seattle | |
Seattle, Washington, United States | |
Canada, Ontario | |
Hospital for Sick Children | |
Toronto, Ontario, Canada | |
Canada, Quebec | |
Hopital Sainte Justine | |
Montreal, Quebec, Canada |
Study Chair: | H. Stacy Nicholson, MD, MPH | Oregon Health and Science University Cancer Institute |
Investigator: | Linda C. Stork, MD | Doernbecher Children's Hospital at Oregon Health & Science University |
Study ID Numbers: | CDR0000334572, COG-ADVL0311, NCI-04-C-0261 |
Study First Received: | October 3, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00070473 |
Health Authority: | United States: Federal Government |
unspecified childhood solid tumor, protocol specific |
Folic Acid Pemetrexed Recurrence |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions |