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

NCT00187109 | Completed Phase 1

• 1 other identifier: TPO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Germ Cell Tumors; Hepatic Cancer; Neuroblastoma; Osteosarcoma; Rhabdomyosarcoma

Keywords

Thrombocytopenia; Platelets; Thrombopoietin

Outcome Measures

Primary Outcomes (2)

• 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.

Interventions

Recombinant Human Thrombopoietin DRUG

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal; Liver Neoplasms; Neuroblastoma; Osteosarcoma; Rhabdomyosarcoma; Thrombocytopenia; Jacobs syndrome

Interventions

Thrombopoietin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Myosarcoma; Neoplasms, Muscle Tissue; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Najat C. Daw, M.D.

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 2000
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: April 10, 2008

Record last verified: 2007-05

Locations

US (1)