Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

NCT00035620 | Completed Phase 2

• 1 other identifier: 990130
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sarcoma; Neutropenia

Keywords

Bone cancer; Sarcoma; Neutropenia; Chemotherapy

Outcome Measures

Primary Outcomes (2)

• Duration of severe neutropenia in chemotherapy in cycles 1 and 3

  cycles 1 and 3

• Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3

  cycles 1 and 3

Secondary Outcomes (3)

• Pharmacokinetic profile in chemotherapy cycles 1 and 3

  cycles 1 and 3

• Incidence of adverse events across all cycles of chemotherapy

  all cycles

• Overall rates of febrile neutropenia

  all cycles

Study Arms (2)

Filgrastim

ACTIVE COMPARATOR

Filgrastim

Drug: filgrastim

Pegfilgrastim

EXPERIMENTAL

Pegfilgrastim

Drug: pegfilgrastim

Interventions

pegfilgrastim DRUG

pegfilgrastim

Pegfilgrastim

filgrastim DRUG

filgrastim

Filgrastim

Eligibility Criteria

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

* Sarcoma \* No previous chemotherapy or radiotherapy \* Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Sarcoma; Neutropenia; Bone Neoplasms

Interventions

pegfilgrastim; Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; 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

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 3, 2002
• First Posted: May 6, 2002
• Study Start: April 1, 2000
• Primary Completion: January 1, 2007
• Study Completion: April 1, 2007
• Last Updated: February 26, 2010

Record last verified: 2010-02