Phase I Study of an Autologous Recombinant Idiotypic Vaccine Manufactured by magnICON® Technology for the Treatment of Patients With Relapsed or Transformed Follicular Lymphoma
Inclusion Criteria:
- Subjects with histologically proven follicular lymphoma (grade 1, 2, or 3a), in
clinical relapse/progression requiring treatment
- Subjects must have had first line treatment consisting of rituximab with or without
rituximab maintenance therapy (i.e. rituximab monotherapy, R-CHOP, R-CVP, R-FND, etc)
- At least 4 months since last rituximab exposure
- Subjects may have had any number of prior treatment regimens. If enrolled with
transformed follicular lymphoma, study subject must have had anthracycline in a
previous regimen
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy of at least 12 months
- Presence of at least a 2x2 cm in diameter lymph node (either a single lymph node or
combined volume of lymphoid tissue) accessible for excision; for histological
confirmation of diagnosis and for manufacture of the vaccine
- Measurable disease in neck, chest, abdomen, or pelvis as assessed by computed
tomography (CT) scan such that response to 2nd line chemotherapy can be defined by
the criteria of Cheson et al (JCO 2007; 25:579, see appendix 15.2 and ref 65). PET
scan results are not required for enrollment
Exclusion Criteria:
- Exposure to rituximab or antiCD-20 directed therapy within the 4 months prior to
enrollment
- History of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis
C virus (HCV) infection
- Active clinically serious infections (> grade 2 National Cancer Institute Common
Toxic Criteria [NCI-CTC] version 3.0)
- Symptomatic metastatic brain or meningeal tumors including lymphoma unless the
patient is > 6 months from definitive therapy, has a negative imaging study within 4
weeks of study entry and is clinically stable with respect to the tumor at the time
of study entry
- History of organ allograft
- Patients undergoing renal dialysis