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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187109
First Posted: September 16, 2005
Last Update Posted: April 10, 2008
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.
Information provided by:
St. Jude Children's Research Hospital
  Purpose
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 Intervention Phase
Germ Cell Tumors Hepatic Cancer Neuroblastoma Osteosarcoma Rhabdomyosarcoma Drug: Recombinant Human Thrombopoietin Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

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

Estimated Enrollment: 40
Study Start Date: June 2000
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00187109


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00187109     History of Changes
Other Study ID Numbers: TPO
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: April 10, 2008
Last Verified: May 2007

Keywords provided by St. Jude Children's Research Hospital:
Thrombocytopenia
Platelets
Thrombopoietin

Additional relevant MeSH terms:
Neuroblastoma
Neoplasms, Germ Cell and Embryonal
Osteosarcoma
Rhabdomyosarcoma
Liver Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Myosarcoma
Neoplasms, Muscle Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Isophosphamide mustard
Carboplatin
Etoposide
Ifosfamide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors