Idiotype Vaccine After Chemotherapy & Stem Cell Transplantation in Lymphoma With Failed Induction Chemotherapy

Lymphoma Clinical Trial

Official title:

Pilot Trial for Idiotype Vaccine Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Patients With Lymphoma Who Had Failed Induction Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574886
• Other study ID #: 0267-00-FB
• Status: Completed
• Phase: N/A
• Start date: August 3, 2000
• Est. completion date: April 15, 2008

Study information

• Verified date: December 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a compassionate use protocol for participants who failed induction chemotherapy + Vaccine on previous trials. These participants then went on to high dose BEAM chemotherapy and transplant, then received idiotype vaccine therapy at 3 months post transplant. Vaccine was given monthly x 4 series, with a fifth series given 12 weeks after the fourth. Participants were then followed annually until progression or death with standard staging.

Description:

This trial was made available as a compassionate use protocol for participants who failed induction chemotherapy + Vaccine on trials 0197-99-FB and 0196-99-FB. These follicular NHL participants then went on to high dose BEAM chemotherapy and transplant. Patients received idiotype vaccine therapy at 3 months post transplant. Vaccine was given monthly x 4 series, with a fifth series given 12 weeks after the fourth. Participants are then followed annually until progression or death with standard staging. Immune response testing continues annually on participants who continue to have a response post transplant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: April 15, 2008
• Est. primary completion date: March 1, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• histologically confirmed aggressive or indolent, B-cell non-hodgkins lymphoma

• original enrollment in vaccine protocol for newly diagnosed lymphoma and had successful production of idiotype vaccine

• failed to achieve PR or CR with initial induction chemotherapy, received salvage chemotherapy and then stem cell transplant and achieved a CR or good PR following transplantation

->/= 19 years

• signed informed consent

• non-pregnant, non-lactating

Exclusion Criteria:

• serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• Id-KLH
Idiotype vaccine - .5mg recombinant idiotype immunoglobulin protein given subcutaneously for a total of five administrations over 6 months.

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Genitope Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Humoral and cellular responses to idiotype vaccine following high-dose chemotherapy and hematopoietic stem cell transplant	Humoral and cellular responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with lymphoma following high-dose chemotherapy and	After vaccination
Secondary	Safety and toxicity of idiotype vaccine post-transplant setting	Safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting	Post-transplant vaccination