Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy
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Purpose
Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric patients up through the age of 21 with sarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma Neutropenia |
Drug: pegfilgrastim Drug: filgrastim |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients |
- Duration of severe neutropenia in chemotherapy in cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]
- Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]
- Pharmacokinetic profile in chemotherapy cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]
- Incidence of adverse events across all cycles of chemotherapy [ Time Frame: all cycles ] [ Designated as safety issue: Yes ]
- Overall rates of febrile neutropenia [ Time Frame: all cycles ] [ Designated as safety issue: No ]
| Enrollment: | 44 |
| Study Start Date: | April 2000 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Filgrastim
Filgrastim
|
Drug: filgrastim
filgrastim
Other Name: filgrastim
|
|
Experimental: Pegfilgrastim
Pegfilgrastim
|
Drug: pegfilgrastim
pegfilgrastim
|
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00035620 History of Changes |
| Other Study ID Numbers: | 990130 |
| Study First Received: | May 3, 2002 |
| Last Updated: | February 25, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Bone cancer Sarcoma Neutropenia Chemotherapy |
Additional relevant MeSH terms:
|
Neutropenia Sarcoma Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Lenograstim Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013