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Home > "C" Clinical Trials Conditions > Cancer Vaccine for Lymphoma following Chemotherapy  Cancer Vaccine for Lymphoma following Chemotherapy
Cancer Vaccine for Lymphoma following Chemotherapy
For Condition: B Cell Lymphoma,Follicular Lymphoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will evaluate the effectiveness of an experimental cancer vaccine for lymphoma. Although currently available lymphoma treatments (radiation therapy and various chemotherapy regimens) may cause a remission of disease, none provides a long-term survival. Patients with lymphoma of the follicular, low-grade type may be eligible for this study. Those enrolled will undergo lymph node biopsy and bone marrow aspiration before beginning treatment. The biopsy involves surgically removing a lymph node from the neck, axilla, or groin. For the bone marrow test, a needle is inserted into the pelvic bone after the skin over the area has been numbed. A sample of bone marrow (blood and tissue) is then withdrawn through the needle. A bone marrow biopsy, in which a piece of the marrow tissue is removed, is done at the same time. After these procedures, patients will start chemotherapy with four drugs prednisone, adriamycin, cytoxan and etoposide administered in 28-day treatment cycles, as follows: Prednisone is taken by mouth days 1-14 of the cycle; the remaining three drugs are given intravenously (through a vein) on day 1 and day 8. No medicine is taken from days 15 to 28. Chemotherapy will continue until the entire tumor is gone or has stopped shrinking (this usually requires 6 to 8 cycles). At the completion of chemotherapy, patients are randomly assigned to one of two vaccination groups: 1. Group I (Id/KLH) Patients in group I will receive injections of a vaccine composed of a protein custom-made from their own tumor cells and another protein called KLH, which, linked to the tumor protein, may help produce an immune response to the tumor. 2. Group II (KLH) Patients in Group II will receive injections of KLH alone. The first vaccination will be given 6 months after chemotherapy ends and will be repeated after 1, 2, 3 and 5 months. The vaccinations will be injected under the skin twice a day. Patients will also receive daily injections of GM-CSF, a growth factor naturally produced by bone marrow that can boost the immune system. These injections will be given the same day as vaccination and for the next 3 days. A second lymph node biopsy may be requested during vaccine treatment. Bone marrow biopsies and aspirates will be repeated after 4, 6 and 8 months of chemotherapy and again at the beginning and end of vaccine therapy to examine the effects of treatment on the tumor and possible side effects of therapy on the bone marrow. Several blood tests will be done before, during and after therapy to monitor the effects of treatment. Leukapheresis a procedure for collecting white blood cells may be done just before beginning chemotherapy and again before beginning vaccine therapy to study T cells (a type of white blood cell important in the immune system). In this procedure, which is similar to donating whole blood, the blood is drawn through a vein and then flows into a cell separator machine, where the white cells are separated and removed. The rest of the blood is then returned to the patient.
Details: The development of a vaccine against human malignancies has been a long-sought goal, which has yet to be achieved. Many of the efforts toward this end have been frustrated by the lack of identification of a tumor-specific antigen which would allow tumor cells to be distinguished from normal cells. Conceptually, such an antigen could be used as a vaccine to induce the host's immune system to reject cells bearing that antigen. Immunoglobulin (Ig) molecules are composed of heavy and light chains, which possess highly specific variable regions at their amino termini. The variable regions of heavy and light chains combine to form the unique antigen-recognition site of the Ig protein. These variable regions contain determinants that can themselves be recognized as antigens, or idiotypes. B-cell malignancies are composed of clonal proliferations of cells synthesizing a single antibody molecule with unique variable regions in the heavy and light chains. B-cell lymphomas are neoplasms of mature resting and reactive lymphocytes, which generally express synthesized lg on the cell surface. The idiotypic determinants of the surface Ig of a B-cell lymphoma can thus serve as a tumor-specific marker for the malignant clone. Studies in experimental animals, as well as in man, have demonstrated the utility of the Ig idiotype as a tumor-specific antigen. Lynch and Eisen were the first to demonstrate that active immunization against idiotypic determinants on malignant B cells could produce resistance to tumor growth, and this phenomenon of idiotype tumor resistance has been reproduced subsequently in a number of syngeneic experimental tumor models, as well as specific anti-tumor therapy against established tumors. These results, taken together, provided the rationale for testing autologous tumor-derived idiotypic surface Ig (Id) as a therapeutic 'vaccine' against human B-cell lymphoma.
Eligibility:
Study Type: Interventional, Treatment, Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA Tissue diagnosis of follicular lymphoma with surface IgM or IgG phenotype with a monoclonal heavy and light chain as determined by Flow Cytometry. When a lymph node is biopsied to produce a vaccine, the NCI will histologically evaluate it. The histology of the biopsy must be Follicular Center Cell (FCC) grade I, II, or IIIa (follicular small-cleaved cell lymphoma, follicular mixed, or follicular large cell lymphoma with centrocytes). Stage II with bulky adenopathy (greater than 5 cm in diameter), Stage III or IV lymphoma. Only chemotherapy naive patients are eligible. Patients may have received Prednisone (less than two months of therapy) Previous treatment with radiation alone (less than or equal to 2 sites) is permissible. A single peripheral lymph node greater than 2 cm size accessible for biopsy/harvest or an abdominal lymph node greater than 2 cm that is accessible for laparoscopic biopsy. Patients with Lymphoma cells circulating in the peripheral blood, maligant pleural effusions, or malignant ascites may be eligible if adequate lymphoma cells are present (greater than 10(9)). ECOG performance status less than 2, unless the performance is directly related to disease and therefore should improve with therapy. Life expectancy of greater than one year. Serum creatinine less than or equal to 1.5 mg/dl unless felt to be secondary to lymphoma. Bilirubin less than or equal to 1.5 mg/dl unless felt to be secondary to lymphoma or Gilbert's disease. SGOT/SGPT less than or equal to 3.5 x 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 Any amount of radiation exceeding 2 sites, including prior total body irradiation (TBI). Presence of antibodies to HIV, hepatitis B surface antigen or other active infectious process. HIV supresses the immune system and causes other abnormalities of immunoregulation. Active infectious processes, including Hepatitis B, also cause abnormalities of immunorelation. This could potentially interfere with the development of an immune response to the tumor antigen. Pregnancy or lactation. Chemotherapeutic agents are known to have teratogenic effects on developing embryos and to cause chromosomal damage to gametes. These agents also cause bone marrow suppression and can be excreted in milk. The effects of this type of vaccine on developing embryos is unknown. Since this therapy is not known to be curative, the potential risks to a fetus surpasses that of recognized benefit to the patient. Fertile men and women must plan to use effective contraception. A beta-HCG level will be obtained in women of childbearing potential. A history of unrelated (non-lymphomatous) neoplasm within the past 10 years other than non-melanoma skin cancer or in-situ cervix cancer. Patients with a prior diagnosis of malignancy more than 10 years may be entered into the study at the discretion of the Principal Investigator. Patients unwilling to give informed consent. Failure to meet any of the eligibility criteria. 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.
Total Enrollment: 563
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Clinical Support Center/NCI 1-888-624-1937
Additional Information:
Study ID Numbers: 000050; 00-C-0050
Study Start Date: December 27, 1999
Record last reviewed: December 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001945
Other Follicular Lymphoma Studies:
1. Cancer Vaccine for Lymphoma following Chemotherapy
2. Vaccination of Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype
3. Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
4. A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma
5. Experimental Drug Mono-dgA-RFB4 to Treat B-Cell Lymphoma
Related Studies:
Other Follicular Lymphoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Cancer Vaccine for Lymphoma following Chemotherapy
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