Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Avastin Plus Rituximab for Patients With B-Cell Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00081861
First received: April 23, 2004
Last updated: April 2, 2012
Last verified: April 2012
  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
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

Primary Outcome Measures:
  • Number of Participants With Response (Complete Response or Progressive Disease) [ Time Frame: After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab), ] [ Designated as safety issue: No ]
    Response criteria according to the International Working Group Recommendations for lymphoma where Complete Response (CR) defined as "complete disappearance" of clinically detectable disease and Progressive Disease defined by disease appearance by complete blood count (CBC), clinical and radiologic findings, and/or sizes of lymph nodes, spleen, and liver. Response measured from first documentation of response to first detection of progression.


Enrollment: 13
Study Start Date: March 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avastin + Rituximab
Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
Drug: Avastin
10 mg/kg given intravenously every 2 weeks for 4 doses.
Other Name: Bevacizumab
Drug: Rituximab
375 mg/m^2 given intravenously weekly for 8 doses, 30 minutes to 1 hour following Bevacizumab.
Other Name: Rituxan

  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
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: NCT00081861

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00081861     History of Changes
Other Study ID Numbers: 2003-0520
Study First Received: April 23, 2004
Results First Received: March 5, 2009
Last Updated: April 2, 2012
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
Rituxan

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

ClinicalTrials.gov processed this record on November 27, 2014