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Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma Clinical research trials and Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma medical trials happen in hundreds of localities 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 typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma. Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma clinical trial. Participants frequently obtain the most expert healthcare available for their Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma  Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
For Condition: stage 3 grade 2 follicular lymphoma,stage 3 grade 1 follicular lymphoma,stage 3 grade 3 follicular lymphoma,stage 4 grade 3 follicular lymphoma,stage 4 grade 2 follicular lymphoma,stage 4 grade 1 follicular lymphoma
Status: Recruiting
Sponsor(s): Genitope ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill cancer cells. It is not yet known which regimen of chemotherapy combined with vaccine therapy is more effective for non-Hodgkin's lymphoma. PURPOSE: Randomizedphase III trial to determine the effectiveness of combination chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Compare the time to tumor progression in patients with stage III or IV follicular B-cell non-Hodgkin's lymphoma treated with cyclophosphamide, prednisone, and vincristine followed by immunotherapy with keyhole limpet hemocyanin with or without autologous tumor-derived immunoglobulin idiotype and adjuvant sargramostim (GM-CSF). - Compare the efficacy of these immunotherapy regimens in terms of converting patients with partial response or unconfirmed complete response to clinical complete response. - Compare the safety and toxic effects of these immunotherapy regimens in this patient population. - Compare the time to treatment failure and survival of patients treated with these regimens. - Correlate the induction of idiotype-specific immune response with clinical benefits of achieving molecular remission in these patients. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients receive cyclophosphamide IV over 30-40 minutes and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 8 courses. At 6 months after completion of chemotherapy, patients maintaining partial response (PR), complete response (CR), or unconfirmed complete response (CRU) receive immunotherapy. Patients are stratified according to participating center and baseline disease status (PR vs CR/CRU). Patients are randomized to one of two treatment arms. - Arm I: Patients receive autologous tumor-derived immunoglobulin idiotype conjugated to keyhole limpet hemocyanin (KLH) subcutaneously (SC) on day 1 and adjuvant sargramostim (GM-CSF) SC on days 1-4 of weeks 0, 4, 8, 12, 16, 20, and 24. - Arm II: Patients receive KLH alone SC on day 1 and GM-CSF SC on days 1-4 of weeks 0, 4, 8, 12, 16, 20, and 24. Quality of life is assessed prior to first immunization, at 2-8 weeks after completion of immunizations, and then every 6 months for 30 months. Patients are followed every 3 months for 1 year and then every 6 months thereafter. Patients also enroll in a long-term follow-up study for an additional 5 years. PROJECTED ACCRUAL: A total of 360 patients (240 in arm I and 120 in arm II) will be accrued from the 480 patients biopsied for this study within 15-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage III or IV follicular B-cell non-Hodgkin's lymphoma - At least 1 bidimensionally measurable lesion by radiography, in addition to lesion removed for biopsy - No clinical evidence of CNS involvement PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - Hepatitis B surface antigen negative - Hepatitis C antibody negative Renal: - Creatinine less than 1.5 times ULN Other: - No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix - No history of autoimmune disease - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior antibody therapy for lymphoma Chemotherapy: - No prior cytotoxic therapy for lymphoma Endocrine therapy: - No prior corticosteroids for lymphoma - At least 12 months since prior corticosteroids or immunosuppressants for other conditions - Prior transient corticosteroids (prior to CT imaging) or optical solutions allowed Radiotherapy: - Prior radiotherapy for lymphoma (no more than 2 sites of limited disease) allowed Surgery: - See Disease Characteristics Other: - No concurrent participation in other therapeutic clinical trial
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LoriKunkel, Study Chair, Genitope
Mountain States Tumor Institute - Boise *Recruiting*
Boise, Idaho, 83712
United States
Recruiting Thomas Beck 208-381-2711
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5151
United States
Recruiting Ronald Levy 650-725-6452
Rocky Mountain Cancer Centers - Midtown *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Jeffrey Matous 303-285-5087
Rush Cancer Institute at Rush University Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Stephanie Gregory 312-942-5982
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting John Leonard 212-746-2095
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Neil Berinstein 415-480-5846
Veterans Affairs Medical Center - Ann Arbor *Recruiting*
Ann Arbor, Michigan, 48105-2399
United States
Recruiting Craig Okada 734-769-7100 ext. 5466
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting Brian Link 319-353-8504
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Christos Emmanouilides 310-206-0716
Sarah Cannon Cancer Center at Centennial Medical Center *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting John Hainsworth 615-986-4300
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Sherif Farag 614-293-7527
SuperGen, Incorporated *Recruiting*
Dublin, California, 94568
United States
Recruiting Craig Rosenfeld 925-560-0100
British Columbia Cancer Agency *Recruiting*
Vancouver, British Columbia, V5Z 4E6
Canada
Recruiting Joseph Connors 604-877-6000 ext. 2746
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0942
United States
Recruiting Craig Okada 734-615-4762
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Kristen Ganjoo 317-278-0080
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Julie Vose 402-559-3848
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Nancy Bartlett 314-362-4843
California Cancer Care, Inc. *Recruiting*
Greenbrae, California, 94904
United States
Recruiting Jennifer Lucas 415-925-5000
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-0277
United States
Recruiting James Lynch 352-846-1145
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Aaron Rapoport 410-328-1230
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97201-3098
United States
Recruiting Craig Nichols 503-494-6346
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Ian Flinn 410-614-5542
Cancer Center at Hackensack University Medical Center *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Scott Rowley 201-996-5900
Cross Cancer Institute *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting Andrew Belch 780-432-8757
Additional Information:
Study ID Numbers: CDR0000068673; GENITOPE-G2000-03,CUMC-0101-142,UCLA-0010061
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017290
Other Stage 4 Grade 1 Follicular Lymphoma Studies:
1. Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma
2. Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
3. Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
Related Studies:
Other stage 4 grade 1 follicular lymphoma Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
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