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Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment Clinical research trials and Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment. Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment clinical trial. Participants frequently get the best healthcare available for their Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment  Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment
Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment
For Condition: recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma,recurrent mantle cell lymphoma,recurrent adult diffuse mixed cell lymphoma,recurrent adult immunoblastic large cell lymphoma,recurrent grade III follicular large cell lymphoma,recurrent adult Hodgkin's disease,recurrent adult diffuse large cell lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Hodgkin's disease or non-Hodgkin's lymphoma that has not responded to previous treatment.
Details: OBJECTIVES: I. Determine the efficacy of gemcitabine, dexamethasone, and cisplatin in patients with relapsed or refractory Hodgkin's disease or aggressive non-Hodgkin's lymphoma. II. Determine the qualitative and quantitative toxicity of this regimen in these two patient populations. PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to disease (Hodgkin's disease vs non-Hodgkin's lymphoma). Patients receive oral dexamethasone on days 1-4, cisplatin IV over 1 hour on day 1, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, 3 months, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 44-88 patients (22-44 per stratum) will be accrued for this study within 4-10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically confirmed Hodgkin's disease OR Histologically or cytologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of B-cell origin (including immunoblastic, anaplastic large cell, mediastinal large B-cell, or T-cell rich B-cell NHL) - No prior diagnosis of low-grade NHL - No histologic evidence of transformation from indolent to aggressive histology Bidimensionally measurable disease that is clinically or radiologically documented - Bone lesions not considered bidimensionally measurable - Lymph nodes at least 1.5 cm by 1.5 cm OR - Other non-nodal lesions at least 1 cm by 1 cm Recurrent or refractory to at least 1 prior chemotherapy regimen (excluding gemcitabine and cisplatin) No known CNS involvement --Prior/Concurrent Therapy-- Biologic therapy: - No prior stem cell transplantation - No concurrent monoclonal antibody therapy - No concurrent growth factors during the first course of study Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior IV chemotherapy - No prior cisplatin or gemcitabine - No prior high-dose chemotherapy - No other concurrent cytotoxic therapy Endocrine therapy: No concurrent corticosteroids, except for physiologic replacement Radiotherapy: - No prior radiotherapy to more than 25% of functioning bone marrow - At least 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery: At least 2 weeks since prior major surgery Other: No other concurrent anti-cancer therapy or experimental therapy --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: - Absolute granulocyte count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST or ALT no greater than 2.5 times ULN Renal: Creatinine less than 1.6 mg/dL Cardiovascular: No significant cardiac dysfunction or cardiovascular disease Other: - HIV negative - No other concurrent or prior malignancy within the past 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix - No other serious illness or medical condition that would preclude study - No active uncontrolled bacterial, fungal, or viral infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelCrump, Study Chair, National Cancer Institute of Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Additional Information:
Study ID Numbers: CDR0000068518; LILLY-CAN-NCIC-LY10,CAN-NCIC-LY10
Study Start Date: December 2000
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014209
Other Recurrent Adult Immunoblastic Large Cell Lymphoma Studies:
1. FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin’s Lymphoma
2. Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma
3. Bevacizumab in Treating Patients With Non-Hodgkin's Lymphoma
4. BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
5. LY317615 in Treating Patients With Relapsed or Refractory Lymphoma
Related Studies:
Other recurrent adult immunoblastic large cell lymphoma Clinical Trials
Other Alberta Clinical Trials
Other Edmonton Clinical Trials
Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment
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