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Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma Clinical research trials and Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma. Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma clinical trial. Test subjects typically obtain the finest healthcare available for their Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma  Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma
Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma
For Condition: recurrent diffuse small lymphocytic/marginal zone lymphoma,Waldenstrom's Macroglobulinemia,recurrent grade I follicular small cleaved cell lymphoma,recurrent grade II follicular mixed cell lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients who have refractory or recurrent Hodgkin's disease or non-Hodgkin's lymphoma.
Details: OBJECTIVES: I. Evaluate the response rate and duration of response to aminocamptothecin (9-AC) in patients with refractory or relapsed Hodgkin's disease or non-Hodgkin's lymphoma. II. Assess the toxicity of 9-AC in these patients. III. Validate a preliminary pharmacodynamic model relating total 9-AC concentration, albumin, and bilirubin to toxicity. IV. Determine whether 9-AC concentrations correlate with response. PROTOCOL OUTLINE: Patients are stratified by disease histology (International Working Formulation (IWF) A-C vs IWF D-F) and center. Patients receive aminocamptothecin IV continuously on days 1-3. Treatment repeats every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease, partial response (PR), or complete response (CR) may receive 2 additional courses past best response (minimum of 6 courses if PR or CR). Patients are followed every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A minimum of 110 eligible patients (40 with low grade non-Hodgkin's lymphoma (NHL), 35 with intermediate grade NHL, and 35 with Hodgkin's disease) will be accrued over 2.5 years. Accrual of patients with intermediate grade NHL and Hodgkin's disease closed effective 04/15/2000.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically documented Hodgkin's disease (closed to accrual 4/15/2000) OR Histologically documented non-Hodgkin's lymphoma (NHL) of one of the following International Working Formulation (IWF) histologies: Small lymphocytic (absolute lymphocyte count less than 5,000): IWF A Follicular, predominantly small cleaved cell: IWF B Follicular mixed: IWF C Follicular large cell: IWF D* Diffuse small cleaved cell: IWF E* Diffuse mixed: IWF F* Diffuse large cell: IWF G* Large cell, immunoblastic: IWF H* * Accrual of patients with these diagnoses closed 4/15/2000 - Pathology review required within 60 days of registration - Refractory to or relapsed after prior chemotherapy as follows: Low-grade NHL (IWF A-C): 1 or 2 prior therapies; Intermediate-grade NHL (IWF D-H): 1 prior therapy (stratum closed 4/15/2000) Hodgkin's disease: 1 or 2 prior therapies (stratum closed 4/15/2000) - Treatment with the same drugs on 2 different schedules considered 1 therapy - Measurable disease by physical exam or imaging studies; Mass larger than 1 x 1 cm; Documented progression required of previously irradiated lesions The following are not considered measurable: Ascites or pleural effusion; Bone marrow involvement; Positive barium studies; Bony disease (lytic lesions noted) - No mantle cell or transformed lymphoma - No parenchymal or leptomeningeal CNS disease [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.] --Prior/Concurrent Therapy-- - Biologic therapy: No prior allogeneic or autologous bone marrow transplant - Chemotherapy: See Disease Characteristics; More than 3 weeks since chemotherapy (6 weeks since nitrosoureas, melphalan, or mitomycin); No prior camptothecin - Endocrine therapy: Not specified - Radiotherapy: More than 3 weeks since radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: CALGB 0-2 - Hematopoietic: (Unless hypersplenism or biopsy-proven bone marrow involvement) Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin normal; AST no greater than 4 times normal - Renal: Creatinine normal - Other: No suspected HIV infection; No second malignancy within past 5 years except: Curatively treated carcinoma of the cervix; Curatively treated basal cell skin cancer; No uncontrolled infection or other serious medical condition; No psychiatric condition that precludes informed consent; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NancyBartlett, Study Chair, Cancer and Leukemia Group B
Cooper Cancer Institute
Camden, New Jersey, 08103
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Washington University Barnard Cancer Center
St. Louis, Missouri, 63110
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Additional Information:
Study ID Numbers: CDR0000064666; CLB-9551
Study Start Date: April 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002745
Other Recurrent Grade I Follicular Small Cleaved Cell Lymphoma Studies:
1. 506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or T-cell Lymphoma
2. Interferon Alfa Plus Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
3. Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
4. Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
5. Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent grade I follicular small cleaved cell lymphoma Clinical Trials
Other New Jersey Clinical Trials
Other Camden Clinical Trials
Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma
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