Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00487305

Purpose

The purpose of this study is to compare the safety and immune activity of three doses of tumor vaccine. In recent years, researchers at the Dana-Farber Cancer Institute have discovered that vaccines made from patient's own cancer cell, that have been engineered in the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer. GM-CSF is a naturally occuring hormone in the body that helps our immune system fight infections and diseases. One of the goals of this study is to determine whether these vaccinations will improve the immune system's ability to recognize and destroy the participant's lymphoma cells.

Condition	Intervention	Phase
Follicular Lymphoma	Biological: Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Trial of Vaccination With Lethally Irradiated Lymphoma Cells Admixed With Granulocyte-Macrophage Colony Stimulating Factor Secreting K562 Cells for the Treatment of Previously Untreated or Relapses Follicular Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the safety and toxicity of administering vaccine composed of lethally irradiated lymphoma cells admixed with GM-CSF secreting K562 cells in patients with follicular lymphoma. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To describe the biologic activity of the study vaccine [ Time Frame: 2 years ] [ Designated as safety issue: No ]
to determine tumor overall response rate as well as complete and partial response rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
to determine progression free survival and overall survival. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Dose will vary depending upon number of cells collected and when the participant is enrolled on the study: the vaccine is given as an injection under the skin once weekly for 3 weeks then every other week for 3 vaccines.

Detailed Description:

The dose of vaccine will depend upon how many of the participant's own tumor cells are available and at which point they join study. This Phase I trial is a "dose escalation" study. This means that participants will be enrolled in groups. Group 2 will receive a larger dose than Group 1. Group 3 will receive a larger dose than Group 2.
The vaccine is administered in injections under and into the skin six times. Participants will receive vaccination shots once weekly for 3 vaccines, then every other week for 3 vaccines.
After the first and fifth vaccinations, a small amount of the participants own lymphoma cells (killed) will be injected under the skin to see if their immune system will react against it and cause redness and swelling. A punch skin biopsy will also be performed at these injection locations.
During the course of the study, we will also be drawing blood to evaluate immune cells and the effect that the vaccinations have on the participants immune system. During all treatment cycles a physical exam and questions about the participants general health will be performed.
After the final treatment (approximately week 10) the participant will undergo "re-staging" to assess the status of their disease. If after completion of six vaccines, evaluation of the participant's disease reveals that it is stable or responding to the vaccine, and there is still vaccine available, they may be eligible to continue to receive the vaccines every two weeks until their supply runs out.
After completion of the vaccinations, participants will come back for physical exams and blood tests every 3 months for 1 year and then once a year for fifteen years to monitor the effects of the vaccine.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed follicular lymphoma
Patients with relapsed follicular lymphoma achieving at least a PR following their most recent systemic chemotherapy and/or immunotherapy regimen.
Lymphoma accessible for sampling or existing cryopreserved lymphoma tumor judged suitable for vaccine preparation.
4 weeks must have elapsed between the completion of the the last chemotherapy, immunotherapy, glucocorticoid therapy, radiotherapy, or experimental therapy.
ECOG Performance Status 0 or 1
Estimated life expectancy of > 6 months
35 years of age or older
Adequate recovery of drug related toxicities, surgery or radiation therapy
Greater than 6 months since autologous stem cell transplantation
Laboratory parameters as outlined in the protocol

Exclusion Criteria:

Uncontrolled active infection or illness
Psychiatric illness/social situation that would limit study compliance
Pregnancy or nursing mothers
Evidence of infection with HIV or viral hepatitis
Other invasive malignancy
Existing autoimmune cytopenia
Previous allogeneic stem cell transplant
Pre-existing autoimmune disease requiring anti-inflammatory therapy
Participation in previous vaccine trial
Any component of grade 3 follicular lymphoma or transformed follicular lymphoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487305

Contacts

Contact: Eric Jacobsen, MD

617-632-6633

edjacobsen@partners.org

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators

Principal Investigator:

Eric Jacobsen, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Eric Jacobsen, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00487305 History of Changes
Other Study ID Numbers:	06-275
Study First Received:	June 15, 2007
Last Updated:	November 11, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

GM-CSF
vaccine
K562

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders

Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on February 09, 2012