Clinical trial NCT00134082
Conditions: Lymphoma
Keywords: recurrent adult Hodgkin lymphoma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2005-11-01; Completion date: 2013-01-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Vaccines made from another person's cancer cells may help the body build an effective immune response to kill cancer cells. Giving rituximab together with chemotherapy and vaccine therapy may kill more cancer cells

PURPOSE: This phase I/II trial is studying how well giving rituximab together with cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin lymphoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the safety and tolerability of rituximab and high-dose cyclophosphamide followed by vaccine therapy comprising an allogeneic vaccine that expresses Hodgkin's tumor antigens and sargramostim (GM-CSF) (KGEL vaccine) as salvage therapy in patients with relapsed Hodgkin lymphoma.
* Determine the immunologic response to this vaccine in these patients.

Secondary

* Determine the 3-year relapse-free and overall survival of patients treated with this regimen.
* Determine the patterns of cellular immune reconstitution in patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive rituximab IV on days -10 and -7 and then on days 29, 36, 43, and 50 (weeks 4-7) and high-dose (transplant-dose) cyclophosphamide IV on days -3 to 0 without stem cell rescue. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover. Patients also receive vaccine therapy comprising an allogeneic vaccine that expresses Hodgkin's tumor antigens and sargramostim (GM-CSF) (KGEL vaccine) intradermally on day 1, and weeks 4, 8, 12, 16, and 24.

After completion of high-dose cyclophosphamide, patients are followed every 3 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.

Arms: arm 1: All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.
Interventions: intervention 1: KGEL vaccine intervention 2: Filgrastim intervention 3: Rituximab intervention 4: Cyclophosphamide
Intervention descriptions: intervention 1: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10\^8 cells per dose. The first dose was given on Day +1. intervention 2: 5 mcg/kg/day starting on Day +6 until ANC is \>= 1000/mcL. intervention 3: 375 mg/m\^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7. intervention 4: 50 mg/kg/day on Day -3, -2, -1, and 0.

Protocol documents: