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Trial record 34 of 57 for:    "Germ Cells Tumors" | "Carboplatin"

Recombinant Human Thrombopoietin in Children Receiving Ifosfamide, Carboplatin, and Etoposide Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00187109
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 10, 2008
Information provided by:
St. Jude Children's Research Hospital

Brief Summary:
Life-threatening thrombocytopenia (low platelet count) and neutropenia (low white blood count) remain the major dose-limiting toxicities following chemotherapy treatment for cancer. The only remedy for thrombocytopenia at present is platelet transfusion, which is effective in preventing life-threatening hemorrhage, but may lead to other complications. Preclinical studies and studies in adults have shown recombinant human thrombopoietin (rhTPO) to be effective in stimulating platelet production. The initial phase of this trial will evaluate the safety of rhTPO use immediately after chemotherapy with ifosfamide, carboplatin, and etoposide in children with solid tumors and lymphomas. The second phase of the study will evaluate the effectiveness of rhTPO in decreasing the duration of low platelet count after chemotherapy.

Condition or disease Intervention/treatment Phase
Germ Cell Tumors Hepatic Cancer Neuroblastoma Osteosarcoma Rhabdomyosarcoma Drug: Recombinant Human Thrombopoietin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Recombinant Human Thrombopoietin in Children With Malignant Solid Tumors and Lymphoma Receiving Ifosfamide, Carboplatin and Etoposide
Study Start Date : June 2000
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Primary Outcome Measures :
  1. To evaluate the safety of recombinant human thrombopoietin following chemotherapy which includes ifosfamide, carboplatin and etoposide for solid tumors and lymphoma.
  2. To evaluate whether recombinant human thrombopoietin will reduce the time necessary for platelet counts to recover following chemotherapy.

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of recurrent, refractory, or previously untreated malignant solid tumor or recurrent/refractory lymphoma for which Ifosfamide, Carboplatin, and Etoposide chemotherapy is the most appropriate treatment.
  • Adequate liver and kidney function.
  • Adequate performance status.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00187109

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United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
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Principal Investigator: Najat C. Daw, M.D. St. Jude Children's Research Hospital

Additional Information:
Layout table for additonal information Identifier: NCT00187109     History of Changes
Other Study ID Numbers: TPO
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 10, 2008
Last Verified: May 2007
Keywords provided by St. Jude Children's Research Hospital:
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Liver Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Isophosphamide mustard
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors