Expired Study
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Memphis, Tennessee 38105


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.


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.


Study is Available At:


Original ID:

TPO


NCT ID:

NCT00187109


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Phase I/II Trial of Recombinant Human Thrombopoietin in Children With Malignant Solid Tumors and Lymphoma Receiving Ifosfamide, Carboplatin and Etoposide


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

St. Jude Children's Research Hospital


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:


Overall Contact Information

Official Name:Najat C. Daw, M.D.
Principal Investigator
St. Jude Children's Research Hospital

Study Dates

Start Date:June 2000
Completion Date:February 2007
Completion Type:Actual
Primary Completion Date:February 2007
Primary Completion Type:Actual
Verification Date:May 2007
Last Changed Date:April 8, 2008
First Received Date:September 13, 2005

Study Outcomes

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

Study Interventions

Intervention Type:Drug
Name:Recombinant Human Thrombopoietin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:St. Jude Children's Research Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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