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A Phase II Study Of Yttrium-ibritumomab (Zevalan) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Phase II Study Of Yttrium-ibritumomab (Zevalan) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase II Study Of Yttrium-ibritumomab (Zevalan) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma Clinical research trials and A Phase II Study Of Yttrium-ibritumomab (Zevalan) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma healthcare trials take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including A Phase II Study Of Yttrium-ibritumomab (Zevalan) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma. A Phase II Study Of Yttrium-ibritumomab (Zevalan) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase II Study Of Yttrium-ibritumomab (Zevalan) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Phase II Study Of Yttrium-ibritumomab (Zevalan) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase II Study Of Yttrium-ibritumomab (Zevalan) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma  A Phase II Study Of Yttrium-ibritumomab (Zevalan) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma
A Phase II Study Of Yttrium-ibritumomab (Zevalan) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma
For Condition: Lymphoma, Mantle-Cell
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: Study of Yttrium-ibritumomab (Zevalin) For the treatment of Patients with Relapsed & Refractory Mantle Cell Lymphoma
Details: Mantle cell lymphoma cells express a protein called CD20. Zevalin is an antibody targeted against CD20, which carries a radioactive material called 90-Yttrium. The radioactivity will be delivered to the cancer cells by the antibody, helping to kill the mantle cell lymphoma cells.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION: - Histologically confirmed relapsed or refractory mantle cell lymphoma requiring treatment. - No anti-cancer therapy for 3 weeks (6 weeks if rituximab,nitrosourea, or Mitomycin C) prior to study initiation, & fully recovered from all toxicities associated with prior surgery, radiation treatment, chemo or immunotherapy. - Signed informed consent. - Age >/= 18 years. - Expected survival >/= 3 months. - Pre-study WHO status 0, 1, or 2. - Acceptable hematologic status within 2 weeks prior to patient registration, including ANC>/=1500/mm3, plt>/=100,000/mm3. - Female patients who are not pregnant or lactating. - Men & women of reproductive potential must use accepted birth control. - Patients previously on Phase II anti-cancer drugs if no long-term toxicity is expected, & patient has been off drug for >/= 8 weeks with no significant post treatment toxicities observed. - Patients determined to have <25% bone marrow involvement with mantle cell lymphoma within 6 weeks of registration. Measurement determined by bilateral bone marrow biopsies. EXCLUSION: - Prior ABMT or PBSC rescue therapy. - Prior radioimmunotherapy. - Presence of CNS lymphoma. - Patients with HIV or AIDS-related lymphoma. - Patients with pleural effusion. - Patients with abnormal liver function: total bilirubin>2.0mg/dL. - Patients with abnormal renal function: serum creatinine > 2.0mg/dL. - Patients who have received prior external beam radiotherapy to >25% of active bone (involved field or regional). - Patients who have received G-CSF or GM-CSF therapy within 2 weeks prior to treatment. - Serious nodal disease or infection which, in the investigator &/or sponsor's opinion, would compromise other protocol objectives. - Major surgery, other than diagnostic surgery, within 4 weeks. - Presence of HAMA reactivity. This result must be available prior to receiving treatment for those pts with prior exposure to murine antibodies or proteins. - Impaired BM reserve: history of failed stem cell collection; plt<100,000 cells/mm3; hypocellular bone marrow (<15% cellularity); marked reduction in bone marrow precursors of 1 or more cell lines. - Presence of leukemia phase of disease defined as peripheral blood absolute lymphocyte count of >5000/uL.
Total Enrollment: 35
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Anas Younes 713-792-2860
Additional Information:
Study ID Numbers: ID01-541;
Study Start Date: April 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038623
Other Lymphoma, Mantle-Cell Studies:
1. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
2. A Phase II Study Of Yttrium-ibritumomab (Zevalan) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma
Related Studies:
Other Lymphoma, Mantle-Cell Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
A Phase II Study Of Yttrium-ibritumomab (Zevalan) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma
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