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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00674193 |
Purpose
RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer may help doctors learn how dactinomycin and vincristine affect the body and how patients will respond to treatment.
PURPOSE: This laboratory study is evaluating how well dactinomycin and vincristine work in treating young patients with cancer.
| Condition | Intervention |
|---|---|
|
Kidney Cancer Leukemia Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Biological: dactinomycin Drug: vincristine sulfate Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: liquid chromatography Other: mass spectrometry Other: pharmacological study |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer |
| Estimated Enrollment: | 260 |
| Study Start Date: | February 2008 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo blood and urine collection prior to, periodically during, and after treatment with dactinomycin and vincristine for pharmacokinetic, pharmacodynamic, and pharmacogenetic analysis. Samples are analyzed using a liquid chromatography-tandem mass spectrometry assay. Genomic DNA extracted from peripheral blood mononuclear cells is isolated and analyzed by polymerase chain reaction and genotyping assays for genetic variation in genes relevant to the pharmacology of dactinomycin and vincristine.
After the final pharmacokinetic sample is collected, patients are followed for up to 6 months.
Eligibility| Ages Eligible for Study: | up to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of cancer, including, but not limited to, any of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| UAB Comprehensive Cancer Center | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Clinical Trials Office - UAB Comprehensive Cancer Center 205-934-0309 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni 501-686-8274 | |
| United States, California | |
| Childrens Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Leo Mascarenhas 323-361-2529 | |
| Children's Hospital of Orange County | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Violet Shen 714-532-8636 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | Recruiting |
| Wilmington, Delaware, United States, 19803 | |
| Contact: Clinical Trials Office - Alfred I. duPont Hospital for Childre 302-651-5755 | |
| United States, Florida | |
| Nemours Children's Clinic | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Eric S. Sandler 904-697-3793 | |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Recruiting |
| Tampa, Florida, United States, 33607 | |
| Contact: Clinical Trials Office - St. Joseph's Cancer Institute 800-882-4123 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Howard M. Katzenstein 404-785-0853 | |
| United States, Illinois | |
| Advocate Christ Medical Center | Recruiting |
| Oak Lawn, Illinois, United States, 60453 | |
| Contact: Sharad Salvi 708-684-4094 | |
| Children's Memorial Hospital - Chicago | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Stewart Goldman 773-880-3270 | |
| United States, Indiana | |
| St. Vincent Indianapolis Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital 317-338-2194 | |
| United States, Kentucky | |
| Kosair Children's Hospital | Recruiting |
| Louisville, Kentucky, United States, 40232 | |
| Contact: Clinical Trials Office - Kosair Children's Hospital 502-629-5500 CancerResource@nortonhealthcare.org | |
| Lucille P. Markey Cancer Center at University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536-0093 | |
| Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379 | |
| United States, Michigan | |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0286 | |
| Contact: Clinical Trials Office - C.S. Mott Children's Hospital 800-865-1125 | |
| United States, Minnesota | |
| Masonic Cancer Center at University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | Recruiting |
| Jackson, Mississippi, United States, 39216-4505 | |
| Contact: Gail C. Megason 601-984-5220 | |
| United States, Missouri | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Maxine Hetherington 816-234-3265 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Robert J. Hayashi 314-454-4118 | |
| United States, New Jersey | |
| Hackensack University Medical Center Cancer Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Clinical Trials Office - Hackensack University Medical Center 201-996-2879 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-2799 | |
| Cleveland Clinic Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
| Rainbow Babies and Children's Hospital | Recruiting |
| Cleveland, Ohio, United States, 44106-5000 | |
| Contact: Yousif (Joe) H. Matloub 216-844-3345 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Rene Y. McNall-Knapp 405-271-5311 | |
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104-9786 | |
| Contact: Richard Aplenc 267-426-7252 | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni 843-792-9321 | |
| United States, Tennessee | |
| East Tennessee Children's Hospital | Recruiting |
| Knoxville, Tennessee, United States, 37901 | |
| Contact: Ray C. Pais 865-541-8266 | |
| St. Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Clinical Trials Office - St. Jude Children's Research Hospital 901-595-4644 | |
| United States, Texas | |
| Baylor University Medical Center - Houston | Recruiting |
| Houston, Texas, United States, 77030-2399 | |
| Contact: Patrick A. Thompson 832-824-4029 | |
| CCOP - Scott and White Hospital | Recruiting |
| Temple, Texas, United States, 76508 | |
| Contact: Arlynn F. Mulne 254-724-2006 | |
| Methodist Children's Hospital of South Texas | Recruiting |
| San Antonio, Texas, United States, 78229-3993 | |
| Contact: Michael S. Grimley 210-575-7268 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Julie R. Park 206-987-2106 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | Recruiting |
| Perth, Western Australia, Australia, 6001 | |
| Contact: Catherine Cole 011-6189340-8238 | |
| Canada, Quebec | |
| Hopital Sainte Justine | Recruiting |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Contact: Yvan Samson 418-656-4141x47191 | |
| Study Chair: | Jeffrey M. Skolnik, MD | Children's Hospital of Philadelphia |
More Information
| Study ID Numbers: | CDR0000559243, COG-ADVL06B1 |
| Study First Received: | May 6, 2008 |
| Last Updated: | November 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00674193 History of Changes |
| Health Authority: | Unspecified |
|
unspecified childhood solid tumor, protocol specific Ewing sarcoma of bone Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET) Ewing sarcoma |
Wilms tumor and other childhood kidney tumors childhood acute lymphoblastic leukemia childhood rhabdomyosarcoma childhood soft tissue sarcoma |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Urogenital Neoplasms Urologic Neoplasms Antibiotics, Antineoplastic Anti-Bacterial Agents Leukemia Neoplasms, Connective and Soft Tissue Neoplasms by Site Urologic Diseases Kidney Neoplasms Dactinomycin Therapeutic Uses Kidney Diseases |
Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Mitosis Modulators Vincristine Enzyme Inhibitors Antimitotic Agents Pharmacologic Actions Carcinoma Protein Synthesis Inhibitors Neoplasms Tubulin Modulators Sarcoma Carcinoma, Renal Cell Adenocarcinoma Antineoplastic Agents, Phytogenic |
