NCT00006478

Brief Summary

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Vaccine therapy may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2 lymphoma

Timeline
Completed

Started Oct 2000

Typical duration for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2000

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2000

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2008

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

November 17, 2010

Completed
Last Updated

September 18, 2023

Status Verified

August 1, 2023

Enrollment Period

7.5 years

First QC Date

November 6, 2000

Results QC Date

October 19, 2010

Last Update Submit

August 22, 2023

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Humoral and Cellular Immune Response

    evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation

    immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression

Secondary Outcomes (3)

  • Safety of Idiotype Vaccine

    At each immunization and at study completion

  • Toxicity of Idiotype Vaccine

    At each immunization and at study completion

  • Changes in Quantitative Bcl-2

    1 year post transplant evaluation and then annually until disease progression

Study Arms (1)

Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation

EXPERIMENTAL

Phase II trial to study the effectiveness, safety \& toxicity of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma. Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Participants receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose.

Biological: autologous tumor cell vaccineBiological: keyhole limpet hemocyaninBiological: sargramostimProcedure: adjuvant therapy

Interventions

autologous tumor cell vaccineBIOLOGICAL
Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation
keyhole limpet hemocyaninBIOLOGICAL
Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation
sargramostimBIOLOGICAL
Also known as: Leukine
Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation
adjuvant therapyPROCEDURE
Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 19 years of age
  • Histologically proven grade I, II, or III follicular non-Hodgkin's lymphoma that failed induction therapy
  • Minimal disease state at day 100 to 6 months post-transplantatio
  • Lymph nodes smaller than 2 centimeters (cm)
  • Less than 20% bone marrow involvement with lymphoma
  • Uncertain complete remission, defined by greater than 75% reduction in the size of the pre-transplantation mass not representing active disease
  • Tissue sample safely accessible by biopsy, needle aspiration, or phlebotomy
  • o Must have adequate circulating lymphoma cells
  • Karnofsky greater than 70%
  • Absolute neutrophil count greater than 1,000/mm\^3 (No restrictions if study vaccine administered at 6 months after transplantation)
  • CD4+ count greater than 200/microliter (No restrictions if study vaccine administered at 6 months after transplantation)
  • Bilirubin less than 2.0 mg/dL (unless due to lymphomatous involvement)
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than 2 times normal (unless due to lymphomatous involvement)
  • Creatinine no greater than 2.0 mg/dL
  • Fertile patients must use effective contraception during and for 6 months after study participation

You may not qualify if:

  • Previously received no more than 2 high-dose chemotherapies before hematopoietic stem cell transplantation
  • Not pregnant or nursing/negative pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, Follicular

Interventions

FANG vaccinekeyhole-limpet hemocyaninsargramostimChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Limitations and Caveats

The Sponsor Genitope suspend development of MyVax in light of the decision made by the FDA March 6, 2008, therefore this trial was halted prematurely leaving insufficient data to analyze.

Results Point of Contact

Title
Bryan Ludwig, Regulatory Coordinator
Organization
University of Nebraska Medical Center Division of Oncology/Hematology
bmludwig@unmc.edu
402-559-8071

Study Officials

  • Julie M Vose, MD

    University of Nebraska

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2000

First Posted

January 27, 2003

Study Start

October 11, 2000

Primary Completion

April 3, 2008

Study Completion

April 3, 2008

Last Updated

September 18, 2023

Results First Posted

November 17, 2010

Record last verified: 2023-08

Locations

US(1)