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

This study has been completed.

First Received on May 31, 2002. Last Updated on October 22, 2010 History of Changes

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

Purpose

Prophylactic use of Filgrastim SD/01 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:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prophylactic Use of Filgrastim SD/01 In Patients With Hodgkin's Disease Receiving ABVD Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma

Drug Information available for: Bleomycin Doxorubicin Doxorubicin hydrochloride Filgrastim Lenograstim Granulocyte colony-stimulating factor Vinblastine sulfate Vinblastine Dacarbazine Bleomycin sulfate

U.S. FDA Resources

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

Primary Outcome Measures:

Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy [ Time Frame: Following ABVD chemotherapy course ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	November 2001
Study Completion Date:	March 2005
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Filgrastim + ABVD Chemotherapy	Drug: Filgrastim SD/01 Other Names: G-CSF Neupogen Drug: Adriamycin Other Names: Doxorubicin Hydrochloride Adriamycin PFS Adriamycin RDF Drug: Bleomycin Other Names: Bleomycin sulfate Blenoxane BLM Drug: Vinblastine Other Name: Velban Drug: DTIC Other Names: DTIC-Dome Dacarbazine

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Anas Younes, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Anas Younes, MD / Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038558 History of Changes
Other Study ID Numbers:	ID01-087
Study First Received:	May 31, 2002
Last Updated:	October 22, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Hodgkin's lymphoma
Dacarbazine
DTIC
DTIC-Dome
Vinblastine
Velban
Bleomycin sulfate
Blenoxane

BLM
Doxorubicin Hydrochloride
Adriamycin
Filgrastim
G-CSF
Neupogen
Pegfilgrastim
granulocyte colony-stimulating factor

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Dacarbazine
Vinblastine
Lenograstim
Antibiotics, Antineoplastic

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012