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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038558
First received: May 31, 2002
Last updated: July 27, 2012
Last verified: July 2012
History of Changes
  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 3

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:

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: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038558     History of Changes
Other Study ID Numbers: ID01-087
Study First Received: May 31, 2002
Last Updated: July 27, 2012
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 May 23, 2013