Protocol Number: 05-C-0031

Title:

Randomized Trial of Patient-Specific Vaccination with Conjugated Follicular Lymphoma-Derived Idiotype with Local GM-CSF in First Complete Remission

Number:

05-C-0031

Summary:

This study will confirm the safety and efficacy of FNHLIdl, a vaccine to treat lymphoma, cancer of the lymph nodes. Various drugs and drug combinations can cause a temporary response in patients whose cancers are not curable through standard chemotherapy. Radiation therapy is also effective. Still, none of those treatments are known to cure people. An idiotype is the structure of an antibody that makes it specific. The Id vaccine would be custom made from a person's tumor protein.

Patients will undergo a complete medical history, physical examination, and testing of blood and urine. Other tests include electrocardiogram (EKG), multigated acquisition (MUGA) scan, echocardiogram (echo), lymph node biopsy, chest X-ray, computerized tomography (CT) scans, and bone marrow biopsy and analysis. Several tests will occur during chemotherapy, before vaccine therapy, and during vaccine therapy. The EKG, MUGA scan, echo test, and CT scan all require that patients lie still for brief periods. The EKG shows the electrical activity of the heart. The MUGA scan is performed by attaching a radioactive substance to red blood cells and then injecting those cells in the bloodstream. A gamma camera takes pictures of the substance as it travels through the bloodstream and into the heart. In the echo test, a transducer, which transmits high-frequency sound waves, picks up echoes of waves from the heart. The CT scan produces a two-dimensional picture of regions of the body.

Four different drugs will be used for chemotherapy, in a regimen called PACE-prednisone, adriamycin, cytoxan, and etoposide. Prednisone is taken orally for Days 1 to 14 in each cycle of 28 days. The other drugs are all given by vein on Days 1 and 8 of the cycle. On Days 15 to 28, no drugs are given. Patients may also receive GM-CSF, a nonexperimental drug, to stimulate bone marrow after chemotherapy. After chemotherapy has finished, patients whose cancer is gone will be randomly assigned to receive a vaccine called Id/KLH or to receive KLH alone. KLH is a protein that, when linked to the tumor protein, may help the body to create an immune response against the cancer.

At least 6 months is needed to produce a special vaccine for a patient's tumor. Much effort goes into creating such a special vaccine for each patient, but there is no guarantee of success. The study will begin with a biopsy of a lymph node, just below the skin in the patient's groin, armpit, or neck. If the nodes are not large enough, the patient may be asked to undergo a laparoscopy. This procedure is done by a special tube inserted through an incision in the abdomen, and a biopsy is done through the tube. If a mini-laparotomy is requested-involving a surgical section of the abdomen-a special consent form is required. When the vaccine has been produced, it will be injected under the patients' skin. Daily GM-CSF will be given under the skin, as close as possible to the vaccination site, on the day of vaccination and for 3 days following each vaccination (4 days per vaccination). The vaccination will be repeated, at 1, 2, 3, and 5 months after that, over a period of 6 months. Treatment with the vaccine and GM-CSF will be given at the clinic, where patients can be carefully observed. Total time of treatment, from the beginning of chemotherapy to the end of the vaccinations, will be about 18 to 20 months.

It is hoped that treatment will cause the lymphoma will go away, although it is not possible to predict a direct benefit. However, knowledge will be gained that may benefit future patients.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Immunotherapy

Indolent

Cytokine

Untreated

Adjuvant

Recruitment Keyword(s):

Follicular Lymphoma

Lymphoma

Condition(s):

Lymphoma, Follicular

Investigational Drug(s):

Biovaxid

Investigational Device(s):

None

Interventions:

Drug: Biovaxid

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Portlock CS, Rosenberg SA. No initial therapy for stage III and IV non-Hodgkin's lymphomas of favorable histologic types. Ann Intern Med. 1979 Jan;90(1):10-3.

Stevenson GT, Stevenson FK. Antibody to a molecularly-defined antigen confined to a tumour cell surface. Nature. 1975 Apr 24;254(5502):714-6.

Stevenson GT, Elliott EV, Stevenson FK. Idiotypic determinants on the surface immunoglobulin of neoplastic lymphocytes: a therapeutic target. Fed Proc. 1977 Aug;36(9):2268-71.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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