Evaluating Dactinomycin and Vincristine in Young Patients With Cancer

NCT00674193 | Completed

• 5 other identifiers: ADVL06B1NCI-2009-00362COG-ADVL06B1CDR0000559243U10CA098543
• Study Type: observational
• Target: 158
• Locations: 3 countries
• Sites: 38

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Population PK parameters for dactinomycin and VCR

  Not Provided

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

  Not Provided

Secondary Outcomes (5)

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

  Not Provided

• Pharmacogenetic profiles of patients receiving dactinomycin and VCR

  Not Provided

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

  Not Provided

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

  Not Provided

• Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes

  Not Provided

Study Arms (1)

Observational (pharmacological 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.

Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Observational (pharmacological study)

laboratory biomarker analysis OTHER

Correlative studies

Observational (pharmacological study)

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients with a diagnosis of cancer, including, but not limited to, any of the following: Acute lymphoblastic leukemia, Ewing sarcoma, Rhabdomyosarcoma, Soft tissue sarcoma, Wilms tumor who are due to receive or receiving dactinomycin and/or vincristine as a component of cancer treatment on another clinical trial

You may qualify if:

• 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

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (38)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Miller Children's Hospital

Long Beach, California, 90806, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Childrens Hospital of Orange County

Orange, California, 92868-3874, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

Location

University of California San Francisco Medical Center-Parnassus

San Francisco, California, 94143, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Nemours Children's Clinic - Jacksonville

Jacksonville, Florida, 32207-8426, United States

Location

Nemours Childrens Clinic - Orlando

Orlando, Florida, 32806, United States

Location

Saint Joseph Children's Hospital of Tampa

Tampa, Florida, 33607, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Advocate Hope Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Mission Hospitals Inc

Asheville, North Carolina, 28801, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6008, Australia

Location

Hospital Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood and urine

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Sarcoma, Ewing; Neuroectodermal Tumors, Primitive, Peripheral; Wilms Tumor

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jeffrey Skolnik

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 7, 2008
• Study Start: February 1, 2008
• Primary Completion: June 30, 2016
• Last Updated: May 17, 2017

Record last verified: 2017-05

Locations

CA (1); US (36); AU (1)