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

St. Jude Children's Research Hospital logo

St. Jude Children's Research Hospital

Status and phase

Completed
Phase 2
Phase 1

Conditions

Osteosarcoma
Hepatic Cancer
Neuroblastoma
Germ Cell Tumors
Rhabdomyosarcoma

Treatments

Drug: Recombinant Human Thrombopoietin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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