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Evaluating Dactinomycin and Vincristine in Young Patients With Cancer

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Childhood Acute Lymphoblastic Leukemia; Childhood Rhabdomyosarcoma; Childhood Soft Tissue Sarcoma; Ewing Sarcoma; Ewing Sarcoma of Bone; Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET); Unspecified Childhood Solid Tumor, Protocol Specific; Wilms Tumor and Other Childhood Kidney Tumors

Intervention: pharmacological study (Other); laboratory biomarker analysis (Other)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Jeffrey Skolnik, Principal Investigator, Affiliation: Children's Oncology Group

Summary

This laboratory study is evaluating how well dactinomycin and vincristine work in treating young patients with cancer. 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.

Clinical Details

Official title: A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Population PK parameters for dactinomycin and VCR

Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition

Secondary outcome:

Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR)

Pharmacogenetic profiles of patients receiving dactinomycin and VCR

Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children

Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes

Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes

Detailed description: PRIMARY OBJECTIVES: I. To characterize the pharmacokinetics (PKs) of dactinomycin in infants, children, and adolescents with cancer. II. To identify demographic or physiological factors that are determinants of dactinomycin disposition. III. To characterize the PKs of vincristine (VCR) in infants, children, and adolescents with cancer. IV. To identify demographic or physiological factors that are determinants of VCR disposition. SECONDARY OBJECTIVES: I. To examine the correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes. II. To explore the PK, pharmacodynamic, and pharmacogenetic relationships of dactinomycin and VCR in children with cancer. 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

Minimum age: N/A. Maximum age: 16 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of cancer, including, but not limited to, any of the following:

- Acute lymphoblastic leukemia

- Ewing sarcoma

- Rhabdomyosarcoma

- Soft tissue sarcoma

- Wilms tumor

- Due to receive or receiving dactinomycin and/or vincristine as a component of cancer

treatment on another clinical trial

- Able to comply with study requirements

- Other concurrent chemotherapeutic agents allowed

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Miller Children's Hospital, Long Beach, California 90806, United States

Children's Hospital Los Angeles, Los Angeles, California 90027, United States

Childrens Hospital of Orange County, Orange, California 92868-3874, United States

Rady Children's Hospital - San Diego, San Diego, California 92123, United States

University of California San Francisco Medical Center-Parnassus, San Francisco, California 94143, United States

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States

Children's National Medical Center, Washington, District of Columbia 20010, United States

Nemours Children's Clinic - Jacksonville, Jacksonville, Florida 32207-8426, United States

Nemours Childrens Clinic - Orlando, Orlando, Florida 32806, United States

Saint Joseph Children's Hospital of Tampa, Tampa, Florida 33607, United States

Childrens Memorial Hospital, Chicago, Illinois 60614, United States

University of Illinois, Chicago, Illinois 60612, United States

Advocate Hope Children's Hospital, Oak Lawn, Illinois 60453, United States

Indiana University Medical Center, Indianapolis, Indiana 46202, United States

Kosair Children's Hospital, Louisville, Kentucky 40202, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

C S Mott Children's Hospital, Ann Arbor, Michigan 48109, United States

Washington University School of Medicine, Saint Louis, Missouri 63110, United States

Columbia University Medical Center, New York, New York 10032, United States

Mission Hospitals Inc, Asheville, North Carolina 28801, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

Rainbow Babies and Childrens Hospital, Cleveland, Ohio 44106, United States

Oregon Health and Science University, Portland, Oregon 97239, United States

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania 15224, United States

Hospital Sainte-Justine, Montreal, Quebec H3T 1C5, Canada

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

East Tennessee Childrens Hospital, Knoxville, Tennessee 37916, United States

St. Jude Children's Research Hospital, Memphis, Tennessee 38105, United States

Driscoll Children's Hospital, Corpus Christi, Texas 78411, United States

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Methodist Children's Hospital of South Texas, San Antonio, Texas 78229, United States

Seattle Children's Hospital, Seattle, Washington 98105, United States

Princess Margaret Hospital for Children, Perth, Western Australia 6008, Australia

Midwest Children's Cancer Center, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: February 2008
Last updated: August 6, 2014

Page last updated: August 23, 2015

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