Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts After Intensive Chemotherapy

Plain-language summary

This study compares Filgrastim with Filgrastim-SD/01 for boosting white blood cell counts after intensive chemotherapy. It included patients aged 25 or younger with certain tumors such as Ewing's sarcoma and rhabdomyosarcoma. It was a Phase 1 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

National Cancer Institute (NCI)

Intervention

Filgrastim, Filgrastim-SD/01

Start date

3/3/2000

Estimated completion

5/20/2009

Countries

United States

Related genes

Locations

• Bethesda, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

* INCLUSION CRITERIA:
* Newly diagnosed histologically proven:

  * Ewing's sarcoma family of tumors, including peripheral neuroectodermal tumors;
  * Alveolar rhabdomyosarcoma;
  * Stage 3 or 4 embryonal rhabdomyosarcoma;
  * Malignant peripheral nerve sheath tumor that is unresectable, incompletely resected with bulk residual disease or metastatic;
  * Synovial cell sarcoma that is unresectable, incompletely resected with bulk residual disease, or metastatic.
* Age equal to or less than 25 years at the time of diagnosis.
* Normal cardiac function (ejection fraction by MUGA or ECHO that is within the institutional normal range).
* Normal serum creatinine for age or creatinine clearance greater than 60 ml/min/1.73m(2).
* Normal liver function (SGPT less than 5 times the upper limit of normal and bilirubin less than 2.5 times the upper limit of normal).
* Normal hematologic function (absolute neutrophil count equal to or greater than 1500/microL, hemoglobin equal to or greater than 9.0 g/dl and platelet count equal to or greater than 100,000/microL).
* Subjects of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.

EXCLUSION CRITERIA:

* Previous chemotherapy or radiotherapy.
* Pregnant or breast feeding females because the chemotherapy administered on this trial could have a detrimental effect on the developing fetus or newborn.
* Histological evidence of tumor infiltration of bone marrow.
* Stage 1 or 2 embryonal rhabdomyosarcomas.