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

NCT00081861 | Completed Phase 2 Results

• 1 other identifier: 2003-0520
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphoma

Keywords

Non-Hodgkin's Lymphoma; B-Cell Lymphoma; Lymphoma; Avastin; Bevacizumab; Rituximab; Rituxan

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Response (Complete Response or Progressive Disease)

  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.

  After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab),

Study Arms (1)

Avastin + Rituximab

EXPERIMENTAL

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; Drug: Rituximab

Interventions

Avastin DRUG

10 mg/kg given intravenously every 2 weeks for 4 doses.

Also known as: Bevacizumab

Avastin + Rituximab

Rituximab DRUG

375 mg/m\^2 given intravenously weekly for 8 doses, 30 minutes to 1 hour following Bevacizumab.

Also known as: Rituxan

Avastin + Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Interventions

Bevacizumab; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived

Results Point of Contact

• Title: Barbara Pro, MD / Associate Professor
• Organization: U.T. M.D. Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Barbara Pro, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2004
• First Posted: April 27, 2004
• Study Start: March 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: April 5, 2012
• Results First Posted: August 26, 2009

Record last verified: 2012-04

Locations

US (1)