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Growth Factor to Prevent Oral Mucositis in Patients With Hematologic Cancer

NCT00004132 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-06-26

No results posted yet for this study

Summary

RATIONALE: Keratinocyte growth factor may prevent symptoms of mucositis in patients receiving radiation therapy and chemotherapy.

PURPOSE: Randomized phase II trial to study the effectiveness of keratinocyte growth factor in preventing oral mucositis in patients who have hematologic cancers and who are undergoing radiation therapy and chemotherapy before autologous peripheral stem cell transplantation.

Conditions

  • Drug/Agent Toxicity by Tissue/Organ
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Oral Complications
  • Radiation Toxicity

Interventions

BIOLOGICAL

filgrastim

BIOLOGICAL

palifermin

DRUG

cyclophosphamide

DRUG

etoposide

DRUG

ifosfamide

PROCEDURE

quality-of-life assessment

RADIATION

radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Christos E. Emmanouilides, MD · Jonsson Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31
Completion
2004-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004132 on ClinicalTrials.gov