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Vaccine Therapy for Follicular Lymphoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Vaccine Therapy for Follicular Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy for Follicular Lymphoma Clinical research trials and Vaccine Therapy for Follicular Lymphoma health trials occur in a lot of 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 potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Vaccine Therapy for Follicular Lymphoma. Vaccine Therapy for Follicular Lymphoma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy for Follicular Lymphoma clinical trial. Human subjects often get the best healthcare possible for their Vaccine Therapy for Follicular Lymphoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy for Follicular Lymphoma  Vaccine Therapy for Follicular Lymphoma
Vaccine Therapy for Follicular Lymphoma
For Condition: Follicular Lymphoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will evaluate the safety and effectiveness of an experimental vaccine to treat patients with follicular lymphoma. The vaccine is made of protein derived from the patient's tumor, incorporated into tiny fat droplets called liposomes, and interleukin-2 (IL-2)-a substance to enhance the vaccine's effectiveness. The vaccine is designed to boost the body's immune response to the tumor. Patients 18 years of age or older with Stage III or IV follicular lymphoma who have had no chemotherapy or PACE (prednisone, adriamycin, cyclophosphamide and etoposide) therapy may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests, urinalysis, chest X-ray, electrocardiogram and computed tomography (CT) scans of the chest, abdomen and pelvis. Other tests, such as ultrasound, magnetic resonance imaging, GI series, intravenous puncture (IVP), may be done, if needed. A CT scan of the head and lumbar puncture for spinal fluid analysis will be done if medically indicated. In addition, patients will undergo the following procedures for screening and/or study purposes: -Tumor biopsy - to obtain a small piece of tumor tissue for microscopic examination and for use in preparing the vaccine. The sample is surgically removed, under local anesthetic. -Leukapheresis - to obtain white blood cells, used to measure the immune response to tumor cells. For this procedure a needle is inserted into each arm, blood is drawn from one arm and circulated through a cell separator machine where the white cells are removed, and the rest of the blood is returned through the needle in the other arm. -Bone marrow aspiration and biopsy - to determine if the tumor has invaded the bone marrow. The hip area is anesthetized and a special needle is inserted for drawing bone marrow from the hipbone. Participants will be divided into two cohorts, according to prior treatment received: Cohort I - No previous chemotherapy (These patients are enrolled primarily at Fox Chase Cancer Center in Philadelphia, PA and at Morristown Memorial Hospital in Morristown, NJ.) -Group A - Patients with easily accessible lymph node in the neck or groin -Group B - Patients without an easily accessible lymph node Cohort II - Previously treated with PACE therapy (These patients are enrolled primarily at the National Cancer Institute, NIH, in Bethesda, MD.) Patients in Cohort 1 will receive the first vaccination as soon as it has been prepared; those in Cohort 2 will receive the first vaccination a minimum of 3 months after chemotherapy ends. Vaccination will be repeated at approximately 1, 2, 3 and 4 months after the initial treatment. Each vaccination will be split in two doses, given the same day. For Cohort 1 Group A patients, half the vaccine will be injected into a lymph node just under the skin and the other half will be injected under the skin in the arm or leg. All other patients will receive injections under the skin at two different sites in the arms or legs. Patients will have a number of blood tests and X-rays before, during and after therapy to monitor the effects of the vaccine and will be followed closely for treatment side effects.
Details: The idiotype of the immunoglobulin on a given B cell malignancy (Id) can serve as a clonal marker. A previous Phase II study in lymphoma patients has demonstrated the principle that autologous Id protein can be formulated into an immunogenic, tumor specific antigen by conjugation to a carrier protein (KLH) and administration with GM-CSF as an adjuvant. The objectives of this study are: 1) primarily to evaluate feasibility and toxicity of a novel vaccine formulation, and 2) secondarily, to preliminarily evaluate the cellular and humoral tumor-specific immune responses, to preliminarily assess the clinical responses to the vaccine, and to seek very preliminary evidence of any immune response to patients given intratumoral vaccinations in easily accessible lymph nodes. Patients with follicular lymphoma, either previously treated or untreated will be accrued. Good Manufacturing Practice vaccine (Oncoquest-L) is formulated by Biomira USA by mixing tumor membrane derived protein (idiotype material), IL-2 and lipid carrier. Patients will be treated with five monthly injections of autologous tumor-derived vaccine. From the standpoint of our laboratory's research agenda, this protocol is designed to meet the objectives of: 1) Development of second generation vaccine formulations, which are easier and less costly to produce and which are expected to be at least as potent as the prototype Id-KLH + GM-CSF vaccine formulation, and 2) To test the efficacy of vaccination against an advanced tumor burden (in addition to the setting of minimal residual disease after induction chemotherapy). From a practical standpoint, manufacture of these patient-specific vaccines will be performed by Biomira USA under an existing CRADA. Biomira USA has filed the IND application and will be the sponsor for this clinical trial. Thus, no request for access to NCI clinical-grade manufacturing or regulatory resources is anticipated.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Tissue diagnosis of Follicular Center Cell lymphoma (FCC) grade 1, 2 or 3 (follicular small cleaved, follicular mixed or follicular large cell lymphoma) with surface IgM, IgG or IgA phenotype with a monoclonal heavy and light chain as determined by flow cytometry. Age greater than or equal to 18 years. Stage III or IV follicular lymphoma. Follicular lymphoma patients previously untreated with chemotherapy or monoclonal antibody therapy or follicular lymphoma patients previously treated with PACE chemotherapy. Patients may have received prednisone (less than 2 months of therapy). These patients should be off steroids for two weeks prior to registration and/or lymph node biopsy. Patients may have had prior treatment with radiation (less than 2 sites). These patients should be off radiation for two weeks prior to registration and/or biopsy. Previously unirradiated lymph nodes will be used for biopsy. In addition, these patients should have unirradiated lymph nodes left post-biopsy to follow clinical response. A single peripheral lymph node of at least 2 cm in size accessible for biopsy/harvest. Karnofsky status greater than or equal to 70%. Life expectancy of greater than one year. Serum creatinine less than or equal to 1.5 mg/dl. Total Bilirubin less than or equal to 1.5 mg/dl unless felt secondary to Gilbert's disease. AST/ALT less than or equal to 3.5 times upper limit of normal. Ability to give informed consent. Ability to return to clinic for adequate follow-up for the period that the protocol requires. EXCLUSION CRITERIA: Presence of antibodies to HIV or hepatitis C or presence of hepatitis B surface antigen or other active infectious process. Patients must not be pregnant or lactating. Fertile men and women must plan to use effective contraception. Patients with previous or concomitant malignancy, regardless of site except curatively treated squamous or basal cell carcinoma of the skin, or effectively treated carcinoma in situ of the cervix. Patient unwilling to give informed consent. Any medical or psychiatric condition that in the opinion of the protocol chairman would compromise the patient's ability to tolerate this treatment. Patient with primary or secondary CNS lymphoma (current or previously treated) will not be eligible. If in the opinion of the protocol chairman, the patient has rapidly progressing lymphadenopathy, bone marrow failure secondary to lymphoma, B symptoms (unexplained fever with temperature greater than 38 degrees C, drenching night sweats, unexplained loss of greater than 10% of body weight in the six months before diagnosis) and/or evidence of neurovascular or organ compromise secondary to lymphoma, the patient will be excluded.
Total Enrollment: 20
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 010069; 01-C-0069
Study Start Date: January 19, 2001
Record last reviewed: April 18, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008996
Other Follicular Lymphoma Studies:
1. Vaccine Therapy for Follicular Lymphoma
2. Cancer Vaccine for Lymphoma following Chemotherapy
3. Vaccination of Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype
4. Comparative Trial between Bexxar and Zevalin
5. Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
Related Studies:
Other Follicular Lymphoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Vaccine Therapy for Follicular Lymphoma
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