Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma

NCT00487305 | Completed Phase 1 DMC

• 1 other identifier: 06-275
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Follicular Lymphoma

Keywords

GM-CSF; vaccine; K562

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• To describe the biologic activity of the study vaccine

  2 years

• to determine tumor overall response rate as well as complete and partial response rates

  2 years

• to determine progression free survival and overall survival.

  2 years

Study Arms (1)

Biological/Vaccine

EXPERIMENTAL

Biological/Vaccine: Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells 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. \--------------------------------------------------------------------------------

Biological: Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells

Interventions

Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells BIOLOGICAL

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.

Biological/Vaccine

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Jacobsen E, Plant A, Redd R, Armand P, McDonough M, Ihuoma U, Fisher DC, LaCasce A, Ritz J, Dranoff G, Freedman A. 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 follicular lymphoma. Leuk Lymphoma. 2024 Dec;65(12):1864-1874. doi: 10.1080/10428194.2024.2381651. Epub 2024 Jul 21.

  PMID: 39034493 DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Eric Jacobsen, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 18, 2007
• Study Start: June 1, 2007
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

US (1)