Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma (NCT01209871) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma
United States9 participantsStarted 2015-02-26
Plain-language summary
This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with lymphoplasmacytic lymphoma. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Tissue diagnosis of lymphoplasmacytic lymphoma with surface immunoglobulin G (IgG), immunoglobulin A (IgA) or immunoglobulin M (IgM) phenotype with a monoclonal heavy and light chain as determined by flow cytometry; all primary diagnostic lymph node and/or bone marrow biopsies will be reviewed at the University of Texas M.D. Anderson Cancer Center (UTMDACC)
* Previously untreated patients with lymphoplasmacytic lymphoma (of any subtype: IgG, IgA, IgM) in the asymptomatic phase
* Patients must provide a lymph node sample of at least 1.5 cm in the long axis, or a bone marrow aspiration sample providing at least 5 million cluster of differentiation (CD)20 and/or CD38+ (approximately 10 ml)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Serum creatinine =\< 1.5 mg/dl and a creatinine clearance \>= 30 ml/min
* Total bilirubin =\< 1.5 mg/dl unless felt secondary to Gilbert's disease
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2 x upper limit of normal
* Ability to provide informed consent, and to return to clinic for adequate follow-up for the period that the protocol requires
* Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 30 days after the last vaccination has been administ…
What they're measuring
1
Maximum tolerated dose defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity according to the National Cancer Institute Common Toxicity Criteria version 4.0