Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT00134082
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • KGEL vaccine — BIOLOGICAL
    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.
  • Filgrastim — BIOLOGICAL
    5 mcg/kg/day starting on Day +6 until ANC is \>= 1000/mcL.
  • Rituximab — BIOLOGICAL
    375 mg/m\^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.
  • Cyclophosphamide — DRUG
    50 mg/kg/day on Day -3, -2, -1, and 0.

Study Details

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.

Key Dates

Start date
Nov 30, 2005
Status verified
Feb 2019
Primary completion
Jan 31, 2013
Completion
Jan 31, 2013

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Immunotherapy
    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.

Primary Outcome Measure

Number of Participants With Grade 3-5 Adverse Events [ Time Frame: Up to 36 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-2410-

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By research site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MD

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