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Trial record 68 of 1150 for:    "Follicular lymphoma"

Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00487305
Recruitment Status : Active, not recruiting
First Posted : June 18, 2007
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Eric Jacobsen, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE June 15, 2007
First Posted Date  ICMJE June 18, 2007
Last Update Posted Date October 30, 2018
Study Start Date  ICMJE June 2007
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2007)
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.
Change History Complete list of historical versions of study NCT00487305 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
  • To describe the biologic activity of the study vaccine [ Time Frame: 2 years ]
  • to determine tumor overall response rate as well as complete and partial response rates [ Time Frame: 2 years ]
  • to determine progression free survival and overall survival. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2007)
  • To describe the biologic activity of the study vaccine
  • to determine tumor overall response rate as well as complete and partial response rates
  • to determine progression free survival and overall survival.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Follicular Lymphoma
Intervention  ICMJE Biological: 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.
Study Arms  ICMJE Experimental: Biological/Vaccine

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.

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Intervention: Biological: Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2007)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2024
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00487305
Other Study ID Numbers  ICMJE 06-275
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Jacobsen, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Jacobsen, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP