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KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma


OBJECTIVES:

- Determine immunologic responses in patients who have completed first-line therapy for
Hodgkin's lymphoma treated with Hodgkin's antigens-GM-CSF-expressing cell vaccine.

- Determine the durability of these immunologic responses in these patients.

- Determine the utility of an Epstein-Barr virus reporter system for monitoring cellular
vaccine responses.

- Determine the safety and tolerability of this vaccine in these patients.

OUTLINE: Beginning 4-6 months after last chemotherapy, patients receive Hodgkin's
antigens-GM-CSF-expressing cell vaccine on day 1. Treatment repeats every 3 weeks for up to
4 courses.

Immunologic responses are serially monitored along with disease status.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of classic Hodgkin's lymphoma

- Must have completed first-line therapy without evidence of disease progression

PATIENT CHARACTERISTICS:

- HIV negative

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No more than 6 months since prior chemotherapy or radiotherapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Immunologic response

Safety Issue:

No

Principal Investigator

Yvette L. Kasamon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

J06143 CDR0000544408

NCT ID:

NCT00478062

Start Date:

April 2007

Completion Date:

June 2008

Related Keywords:

  • Lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410