Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma

December 18, 2013 updated by: Genitope Corporation

A Phase II Study to Evaluate Safety and Efficacy of Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH and GM-CSF Following the Anti-CD20 Antibody, Rituximab, in Previously Treated Patients With Follicular Non-Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood.

PURPOSE: Phase II trial to study the effectiveness of rituximab followed by vaccine therapy and sargramostim in treating patients who have refractory or progressive non-Hodgkin's lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine progression-free survival in patients with refractory or progressive follicular non-Hodgkin's lymphoma treated with immediate or delayed autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim after rituximab (groups I and II).
  • Determine the immune response rate in patients treated with these regimens (groups I, II, and III).
  • Determine the safety and toxicity of these regimens in these patients (groups I, II, and III).

OUTLINE: This is an open-label, multicenter study for patients previously registered on and confirmed ineligible for randomization in protocol Genitope-G2000-03.

Patients receive rituximab IV weekly for 4 weeks.

  • Group I: The first 30 patients to achieve and maintain a partial response (PR) or better receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously (SC) on day 1 and sargramostim SC on days 1-4 beginning 26 weeks after the last dose of rituximab. Treatment repeats every 2 weeks for 14 weeks (8 immunizations).
  • Group II: All subsequent patients who achieve a PR or better receive autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC as in group I beginning 13 weeks after the last dose of rituximab.
  • Group III: Patients who are not eligible for group I or II and, in the investigator's opinion, are suitable candidates for immunization with autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC receive the same treatment as groups I and II, beginning no more than 1 year after the last (fourth) dose of rituximab.

In all groups, treatment continues in the absence of unacceptable toxicity or emergence of an illness that may interfere with study assessments.

Patients are followed for initial response 8 weeks after completion of immunizations and then every 12 weeks for an additional year. Thereafter, all immunized patients will be followed every 6 months until receipt of first subsequent anti-lymphoma therapy.

PROJECTED ACCRUAL: Up to 120 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute at University of Alberta
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
  • United States
    • California
      • Stanford, California, United States, 94305-5151
        • Stanford Cancer Center at Stanford University Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Cancer Institute at Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10021
        • New York Weill Cornell Cancer Center at Cornell University
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Cancer Institute at Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed follicular center cell non-Hodgkin's lymphoma
  • Stage III or IV disease at time of entry on Genitope-G2000-03
  • At least 1 bidimensionally measurable lesion (1.5 cm X 1.5 cm) by radiography
  • Previously registered on and confirmed to be ineligible for randomization on Genitope-G2000-03 by failing to achieve or maintain a complete or partial response after chemotherapy by CT scans of the chest, abdomen, and pelvis (and neck if there was palpable disease)
  • Completed all 8 courses of chemotherapy (cyclophosphamide, vincristine, and prednisone [CVP]) per Genitope-G2000-03
  • No intervening therapy for lymphoma (i.e., antibody, corticosteroids, or cytotoxic) between CVP and study entry
  • No evidence of transformation (e.g., rapid tumor growth or increasing lactic dehydrogenase)
  • No CNS involvement

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after the last immunization series
  • HIV negative
  • No history of autoimmune disease or conditions requiring treatment with immunosuppressive agents, including corticosteroids
  • No other malignancy within the past 2 years except non-basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • See Disease Characteristics
  • At least 6 months since prior corticosteroids, including topical administration for any concurrent disease

  • No concurrent chronic (more than twice monthly) corticosteroids (including topical or inhaled)

    • Transient use (prior to CT scan) or optical solutions allowed

Radiotherapy

  • Prior radiotherapy to no more than 2 sites more than 13 weeks before rituximab is allowed

Surgery

  • Not specified

Other

  • No concurrent participation in other therapeutic clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival (PFS) in groups I and II and median PFS by Kaplan-Meier curves quarterly for 1 year and then twice a year after study completion

Secondary Outcome Measures

Outcome Measure
Immune response rates in patients who received at least 4 immunizations by anti-idiotype antibody and anti-KLH antibody assays during every other immunization, last immunization, 2 and 8 weeks post immunization, and then quarterly for 1 year
Clinical response in patients who received at least 1 immunization in groups I and II by modified Cheson criteria post-immunization and then every 6 months for 1 year
Safety at the start of immunization, every 8 weeks during immunization, 2 and 8 weeks post immunization, and then quarterly for 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genitope Corporation

Investigators

  • Study Chair: Martha Mayo, PharmD, Genitope Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

November 4, 2003

First Submitted That Met QC Criteria

November 5, 2003

First Posted (Estimate)

November 6, 2003

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000269810
  • GENITOPE-2002-09
  • IUMC-0212-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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