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FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade 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 by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma Clinical research trials and FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma. FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma clinical trial. Test subjects typically receive the most effective healthcare possible for their FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health 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 > "F" Clinical Trials Conditions > FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma  FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma
FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma
For Condition: recurrent grade 2 follicular lymphoma,recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent grade 1 follicular lymphoma
Status: Recruiting
Sponsor(s): University of Maryland Greenebaum Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as FR901228 and fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Rituximab may increase the effectiveness of chemotherapy drugs by making cancer cells more sensitive to the drugs. PURPOSE: Phase I/II trial to study the effectiveness of FR901228 alone or combined with rituximab and fludarabine in treating patients who have relapsed or refractorylow-gradeB-cellnon-Hodgkin's lymphoma.
Details: OBJECTIVES: Primary - Determine the clinical efficacy of single-agent FR901228 (depsipeptide), in terms of complete and partial response rates, in patients with relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma. (Phase II) - Determine the feasibility of adding FR901228 to a rituximab and fludarabine combination regimen in these patients. (Phase I) - Determine the maximum tolerated dose of FR901228 when administered with this combination regimen in these patients. (Phase I) Secondary - Correlate changes in histone acetylation assays with disease response (clinical outcome) in patients treated with this regimen. - Determine the minimal residual disease by immunohistochemistry in patients treated with this regimen. OUTLINE: This is a multicenter, phase II study of single-agent FR901228 followed by a phase I, dose-escalation study of FR901228. - Patients receive FR901228 IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete or partial remission receive 2 additional courses (for a total of 6 courses). Patients with stable disease after 4 courses or progressive disease at any time after 2 courses proceed to the phase I portion of the study. - Patients receive rituximab IV over approximately 4-8 hours on day 1; fludarabine IV over 10-30 minutes on days 2-4; and FR901228 IV over 4 hours on days 2, 9, and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of FR901228 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed for up to 3 years from study entry. PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for the phase II portion of this study within 9 months. A total of 3-24 patients will be accrued for the phase I portion of this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically and clinically confirmed low-grade follicular B-cell non-Hodgkin's lymphoma (NHL), including the following subtypes: - Follicular small cleaved cell - Follicular mixed small and large cell - Small lymphocytic lymphoma - CD20-positive by immunohistochemistry or flow cytometry - Relapsed and/or refractory disease - Received at least 1, but no more than 4, prior chemotherapy regimens for low-grade follicular NHL - For phase II, prior therapies may have included rituximab or fludarabine as a single agent only - For phase I, prior rituximab and fludarabine must not have been administered in combination or sequentially - Prior rituximab and/or fludarabine as single agents are allowed provided patient achieved a 50% response (i.e., partial response to prior therapy) - Measurable disease 4 weeks after the last chemotherapy regimen, meeting at least 1 of the following criteria: - At least 1 unidimensional lesion > 1.5 cm by CT scan - Positive bone marrow biopsy - No bulky disease (single mass 10 cm) - No known CNS involvement by MRI and/or cerebrospinal fluid examination NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 4 months Hematopoietic - Absolute neutrophil count 1,000/mm^3 (500/mm^3 for bone marrow involvement by lymphoma) - Platelet count 100,000/mm^3 (50,000/mm^3 for bone marrow involvement by lymphoma) Hepatic - Bilirubin 1.5 times upper limit of normal (ULN) - AST/ALT 3 times ULN Renal - Creatinine 1.5 times ULN Cardiovascular - No prior life-threatening arrhythmias - No myocardial infarction within the past 6 months - No severe coronary artery disease - No cardiomyopathy - No New York Heart Association class II-IV congestive heart failure - Ejection fraction > 40% - No EKG abnormality (i.e., ischemic ST-T abnormalities, QT prolongation, pathologic q waves, or arrhythmias) - Benign premature atrial or ventricular contractions or first- or second-degree atrioventricular block allowed Other - No prior life-threatening allergic reaction to study agents - No other prior malignancies except basal cell carcinoma or cervical intra-epithelial neoplasia - No prior uncontrolled seizures - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 (1 highly active and 1 additional effective) methods of contraception PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - More than 6 weeks since prior rituximab and recovered - Concurrent growth factors (e.g., filgrastim [G-CSF] or epoetin alfa) allowed - No prior allogeneic stem cell transplantation Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered - More than 6 weeks since prior fludarabine and recovered (phase II) - No prior FR901228 or any other histone deacetylase inhibitor Endocrine therapy - No concurrent pharmacological doses of corticosteroids for concurrent medical conditions Radiotherapy - More than 4 weeks since prior radiotherapy and recovered Surgery - Not specified Other - More than 8 weeks since prior UCN-01 and recovered - No concurrent drugs that would cause prolongation of QTc - No other concurrent investigational agents - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AshrafBadros, Study Chair, University of Maryland Greenebaum Cancer Center
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201-1592
United States
Recruiting Ashraf Badros 410-328-2565
Additional Information:
Study ID Numbers: CDR0000355763; MSGCC-0307,NCI-6015
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079443
Other Recurrent Grade 1 Follicular Lymphoma Studies:
1. Rituximab With or Without Interleukin-12 in Treating Patients With Non-Hodgkin's Lymphoma
2. Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer
3. Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma
4. Monoclonal Antibody Therapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma
5. Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent grade 1 follicular lymphoma Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma
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