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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bleomycin
Doxorubicin
Lenograstim
Liposomal doxorubicin
Vinblastine
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014