|
Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Clinical research trials and Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma. Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma clinical trial. Human subjects often receive the most effective healthcare possible for their Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
For Condition: Lymphoma, B-Cell
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: Phase II Study of Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Must have bi-dimensionally measureable, 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 tachyrrhythmia, 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 proteinurea (patients with >1+ proteinurea 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.
Total Enrollment: 40
Location and Contact Information:
UT MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Anas Younes 713-792-2860
Additional Information:
Study ID Numbers: 2003-0520;
Study Start Date: March 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081861
Other Lymphoma, B-Cell Studies:
1. Phase II Study of Proteasome Inhibitor PS-341 For Patients With Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy
2. Campath-1H and Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies
3. Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
4. Treatment of Non-Hodgkin's Lymphoma with 90Y-hLL2 IgG
5. A Safety/Efficacy Study of SGN-30 (Antibody) in Patients with Refractory or Recurrent CD30+ Hematologic Malignancies
Related Studies:
Other Lymphoma, B-Cell Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
|
|
|
|
|
|
|
|