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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: | NCT00674193 |
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 |
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Kidney Cancer Leukemia Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: dactinomycin Drug: vincristine sulfate Procedure: liquid chromatography Procedure: mass spectrometry Procedure: pharmacological study Procedure: polymerase chain reaction Procedure: polymorphism analysis |
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.
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:
Study Chair: | Jeffrey M. Skolnik, MD | Children's Hospital of Philadelphia |
Study ID Numbers: | CDR0000559243, COG-ADVL06B1 |
Study First Received: | May 6, 2008 |
Last Updated: | December 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00674193 |
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 |
Leukemia, Lymphoid Neuroectodermal Tumors, Primitive Ewing's family of tumors Malignant mesenchymal tumor Urogenital Neoplasms Urologic Neoplasms Kidney cancer Soft tissue sarcomas Leukemia Neoplasms, Connective and Soft Tissue Ewing's sarcoma Sarcoma, Ewing's Urologic Diseases Dactinomycin Kidney Neoplasms |
Wilms Tumor Neuroepithelioma Kidney Diseases Rhabdomyosarcoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Wilms' tumor Vincristine Renal cancer Carcinoma Neuroectodermal Tumors Peripheral neuroectodermal tumor Carcinoma, Renal Cell Sarcoma Adenocarcinoma Urinary tract neoplasm |
Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Antibiotics, Antineoplastic Pharmacologic Actions |
Protein Synthesis Inhibitors Anti-Bacterial Agents Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Nucleic Acid Synthesis Inhibitors |