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Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Clinical research trials and Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia. Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia clinical trial. Test subjects typically receive the most expert healthcare available for their Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia  Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
For Condition: Lymphoma,Leukemia
Status: Completed
Sponsor(s): Pharmatech Oncology ,
Synopsis: RATIONALE: Drugs used in chemotherapy use 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. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining pentostatin and rituximab in treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Details: OBJECTIVES: I. Determine the response rate in patients with low-grade B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with pentostatin and rituximab. II. Determine the duration of response, median time to progression, and survival of patients treated with this regimen. III. Determine the safety of this regimen in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive rituximab IV alone on day 1 of course 1 only. Patients then receive rituximab IV and pentostatin IV on days 8, 15, and 22. An additional course with both drugs is administered on days 36, 43, and 50. Patients with progressive disease or a complete response receive no further treatment. Patients with responsive disease, but less than a complete response, receive one additional course of therapy as above. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 50 non-Hodgkin's lymphoma and 50 chronic lymphocytic leukemia patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed low-grade non-Hodgkin's lymphoma - REAL classification: *B-cell chronic lymphocytic leukemia *Prolymphocytic leukemia *Small lymphocytic lymphoma *Follicular center lymphoma (grade I, II, or III) *Extranodal marginal zone B-cell lymphoma Malt type - International Working Group classification: *Small lymphocytic/chronic lymphocytic leukemia (CLL) [CLL with lymph node involvement allowed] *Small lymphocytic plasmacytoid *Follicular small cleaved cell *Follicular mixed small and large cell *Follicular predominantly large cell Measurable disease - Lymph node more than 1 cm in longest transverse diameter 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 terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. --Prior/Concurrent Therapy-- Biologic therapy: - Prior rituximab, Y2B8, or iodine I 131 tositumomab allowed provided at least 6 months have elapsed and patient has had clear disease progression - No other concurrent immunotherapy Chemotherapy: - No more than 6 prior chemotherapy drugs - No more than 3 prior treatments with pentostatin - At least 3 weeks since prior chemotherapy - No prior cumulative lifetime dose of more than 480 mg/m2 of doxorubicin or an equivalent dose of any anthracycline - No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy to an indicator lesion Surgery: Not specified Other: No other concurrent investigational drug --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 6 months Hematopoietic: - Absolute neutrophil count at least 1,000/mm3 - Platelet count at least 75,000/mm3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST no greater than 5 times upper limit of normal Renal: - Creatinine less than 2.0 mg/dL - BUN normal - Urinalysis normal Cardiovascular: LVEF normal in patients with history of stable heart disease for at least 2 years Other: - HIV negative - No thyroid disease with thyroid function that cannot be maintained in the normal range - No other prior malignancy unless progression free for more than 5 years - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JudyPoehlman, Study Chair, Pharmatech Oncology
Oncology-Hematology Associates, P.A.
Clinton, Maryland, 20735
United States
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, 11733
United States
Hematology Oncology Associates of Central New York, P.C.
Syracuse, New York, 13210
United States
Cancer and Blood Institute of the Desert
Rancho Mirage, California, 92270
United States
Redding Medical Center
Redding, California, 96001
United States
Additional Information:
Study ID Numbers: CDR0000069021; PHARMATECH-20001631,SUPERGEN-PHARMATECH-N007,PHARMATECH-N007
Study Start Date: December 2000
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026351
Other Leukemia Studies:
1. Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
2. Pharmacokinetic study of palifermin in subjects receiving radiation therapy and chemotherapy followed by blood stem cell support
3. Chemotherapy Plus Donor White Blood Cell Infusion in Treating Patients With Relapsed Hematologic Cancer Following Donor Peripheral Stem Cell Transplantation
4. Bleomycin in Treating Patients With Non-Hodgkin's Lymphoma
5. Stem Cell Transplantation in Treating Patients with Hematologic Cancer
Related Studies:
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Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
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