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

NCT00574886 | Completed DMC

• 1 other identifier: 0267-00-FB
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety and toxicity of idiotype vaccine post-transplant setting

  Post-transplant vaccination

Study Arms (1)

1 High dose BEAM chemotherapy, transplant & idiotype vaccine therapy

EXPERIMENTAL

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.

Biological: Id-KLH

Interventions

Id-KLH BIOLOGICAL

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

Also known as: Vacmun KLH

1 High dose BEAM chemotherapy, transplant & idiotype vaccine therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead
• Genitope Corporation: collaborator

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Julie Vose, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 17, 2007
• Study Start: August 3, 2000
• Primary Completion: March 1, 2002
• Study Completion: April 15, 2008
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

US (1)