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Avastin Plus Rituximab for Patients With B-Cell Non-Hodgkin's Lymphoma
This study has been completed.
First Received: April 23, 2004   Last Updated: September 17, 2007   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
Genentech
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00081861
  Purpose

Phase II Study of Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma.


Condition Intervention Phase
Lymphoma
Drug: Avastin (Bevacizumab)
Drug: Rituximab
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Avastin Plus Rituximab for Patients With Relapsed and Chemotherapy- or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


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

Estimated Enrollment: 40
Study Start Date: March 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must have bi-dimensionally measurable, recurrent or chemotherapy - or Rituxan-refractory aggressive B-cell NHL (Diffuse large B-cell, transformed B-cell lymphoma, or Mantle cell lymphoma)
  • Patient who relapse after autologous (not allogeneic) stem cell transplantation are eligible.
  • Patients must have had prior Rituximab therapy, with response duration of at least 6 months to the last Rituximab-based therapy (single agent or in combination)
  • No anti-lymphoma therapy within the past 3 weeks, and no radiation therapy within 2 weeks.
  • Patients must not be eligible for treatment of a higher priority.
  • Must have a good performance status (<3 Zubrod, >/=60 Karnofsky).
  • Must have a good marrow reserve: ANC >/=1,000, Platelets >/=75,000.
  • Bilirubin </= 2mg/dl, SGOT or SGPT </= x 5 normal values.
  • Age > 18 (There is no information about the toxicity of Bevacizumab especially adverse effects on growth and development in pediatric patients).
  • Must sign a consent form.
  • Must have a life expectancy of > 12 weeks.

Exclusion Criteria:

  • HIV positive
  • History of serious cardiac disease such as myocardial infarction within 6 months of treatment, brady- or tachyarrhythmia, or clinically uncontrolled hypertension (blood pressure >160/110 mmHg).
  • Active infection or history of opportunistic infection.
  • Pregnant women or breast-feeding women.
  • Women of child-bearing age who are not practicing adequate contraception.
  • History of prior DVT or pulmonary embolus.
  • INR > 1.5
  • Serum creatinine > 2mg/dl, or clinically significant proteinuria (patients with >1+ proteinuria should have 24 hour urine collection and those with >2gm/day should be excluded).
  • Evidence of bleeding diathesis or coagulopathy.
  • History of other cancers within 5 years except for basal cell carcinoma of the skin.
  • Radiotherapy within 14 days of Day 0.
  • Current, recent (within 21 days of Day 0), or planned participation in an experimental drug study.
  • Hemoglobin <9gm/dl (may be transfused or receive epoetin alfa [e.g., Epogen]to maintain or exceed this level).
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • History of CNS disease (including CNS involvement from primary cancer) or hemorrhagic or thrombotic stroke within the last 6 months.
  • History of hemoptysis requiring transfusion and/or hospitalization within the last 5 years.
  • Anatomic lesion that increase the risk of serious hemorrhage (e.g., invasion of a major vessel by tumor).
  • Current, ongoing treatment with full-dose warfarin or its equivalent.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0.
  • Fine needle aspirations, indwelling catheter placement, or core biopsy within 7 days prior to Day 0.
  • Anticipation of need for major surgical procedure during the course of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00081861

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech
Investigators
Principal Investigator: Barbara Pro, MD U.T. M.D. Anderson Cancer Center
  More Information

No publications provided

Study ID Numbers: 2003-0520
Study First Received: April 23, 2004
Last Updated: September 17, 2007
ClinicalTrials.gov Identifier: NCT00081861     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Non-Hodgkin's Lymphoma
B-Cell Lymphoma
Lymphoma
Avastin
Bevacizumab
Rituximab

Study placed in the following topic categories:
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Bevacizumab
Angiogenesis Inhibitors
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
B-cell Lymphomas
Lymphoma, Non-Hodgkin
Aggression
Lymphoproliferative Disorders
Antirheumatic Agents
Lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Growth Substances
Physiological Effects of Drugs
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions
Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on July 02, 2009