Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy

This study has been terminated.

First Received: May 31, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038558

Purpose

For patients with Hodgkin's lymphoma receiving ABVD chemotherapy.

Condition	Intervention	Phase
Hodgkin Disease	Drug: Filgrastim SD/01 Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Resource links provided by NLM:

MedlinePlus related topics: Hodgkin Disease Lymphoma

Drug Information available for: Bleomycin Doxorubicin Doxorubicin hydrochloride Myocet Filgrastim Vinblastine sulfate Vinblastine Bleomycin sulfate

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	25
Study Start Date:	November 2001

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION:

Previously untreated Hodgkin's disease patients who are scheduled to receive standard ABVD chemo.
Histologically proven diagnosis of Hodgkin's disease of any type.
Bidimensionally measurable disease.
Signed informed consent.
Age >/= 16 yrs.
Adequate bone marrow reserve (ANC>1000/uL, Platelet >100,000/uL.
LVEF>/=50% by MUGA scan or echocardiogram.
Serum creatinine <2mg/dL; serum bilirubin<2mg/dL.

EXCLUSION:

HIV positive.
Pregnant women and those of child bearing age who are not using adequate contraception.
Prior chemotherapy.
Severe pulmonary disease including COPD and asthma.
History of prior sensitivity to E.coli derived products.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038558

Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

More Information

No publications provided

Study ID Numbers:	ID01-087
Study First Received:	May 31, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00038558 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

HODGKIN'S LYMPHOMA

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Mitosis Modulators
Vinblastine
Antimitotic Agents
Antibiotics, Antineoplastic
Bleomycin

Pharmacologic Actions
Doxorubicin
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Tubulin Modulators
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Hodgkin Disease
Lymphoma

ClinicalTrials.gov processed this record on November 25, 2009