Vaccine Therapy Plus Sargramostim Following Chemotherapy in Previously Untreated Aggressive Non-Hodgkin's Lymphoma

September 3, 2023 updated by: University of Nebraska

A Phase II Trial to Evaluate the Rate of Immune Response Using Idiotype Immunotherapies Produced by Molecular Biological Means for Treatment of Aggressive B Cell Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines 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 and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial of vaccine therapy plus sargramostim following chemotherapy in treating patients who have previously untreated aggressive non-Hodgkin's lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the ability of recombinant idiotype immunotherapy to stimulate a specific immune response against the B cell idiotype of the malignant clone that constitutes the tumor in patients with previously untreated aggressive non-Hodgkin's lymphoma. II. Determine the safety and toxicity of this treatment regimen using Genitope Corporation's molecular rescue technology in this patient population.

OUTLINE: Patients receive induction chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or cyclophosphamide, mitoxantrone, vincristine, and prednisone (CNOP). Treatment repeats every 3 weeks until the maximal clinical response is achieved followed by 2 additional courses of consolidation therapy for up to a maximum of 6 courses. At 2-6 months following completion of chemotherapy, patients achieving adequate disease response receive vaccination consisting of recombinant tumor derived immunoglobulin idiotype with keyhole limpet hemocyanin conjugate subcutaneously (SQ) followed by sargramostim (GM-CSF) SQ, each at 2 separate sites on day 1. Patients receive GM-CSF alone on days 2-4. Vaccination repeats every 4 weeks for 4 doses, followed 3 months later by the fifth and final dose. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter until disease progression.

PROJECTED ACCRUAL: Not specified

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

  • United States
    • California
      • Stanford, California, United States, 94305-5408
        • Stanford University Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3330
        • University Of Nebraska Medical Center

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 to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed aggressive non-Hodgkin's lymphoma

    • Diffuse mixed cell
    • Diffuse large cell
    • Immunoblastic Follicular large cell with more than 50% large cells
    • Mantle cell
  • Non-age adjusted International Prognostic Index 2-4
  • Tumor sample safely accessible by biopsy, needle aspiration, or phlebotomy
  • Must have adequate circulating lymphoma cells
  • Over 18 years old
  • Karnofsky 80-100%
  • WBC greater than 2,500/mm3
  • Platelet count greater than 100,000/mm3
  • Hemoglobin at least 10 g/dL
  • Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 2 times normal
  • Creatinine less than 2.0 mg/dL
  • Fertile patients must use effective contraception during and for 6 months after the study
  • At least 2 months since prior nonphysiologic doses of prednisone of greater than 20 mg or equivalent
  • HIV negative

Exclusion Criteria:

  • No CNS metastasis
  • No other illness or condition, including innate or pharmacologic immunosuppression, that would preclude study
  • No other malignancy within the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing/negative pregnancy test
  • No prior biologic therapy for lymphoma
  • No prior cytotoxic chemotherapy for lymphoma
  • No prior steroids for lymphoma
  • No concurrent maintenance steroids or greater than 5mg of daily prednisone or equivalent
  • No prior radiotherapy for lymphoma

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

Collaborators and Investigators

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

Sponsor

University of Nebraska

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Julie M Vose, MD, University of Nebraska

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 (Actual)

June 25, 1999

Primary Completion (Actual)

January 1, 2002

Study Completion (Actual)

November 20, 2003

Study Registration Dates

First Submitted

January 21, 2000

First Submitted That Met QC Criteria

June 24, 2004

First Posted (Estimated)

June 25, 2004

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 3, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0197-99-FB
  • P30CA036727 (U.S. NIH Grant/Contract)
  • GENITOPE-9902 (Other Grant/Funding Number: Genitope Corporation)
  • SUMC-9902 (Other Grant/Funding Number: Supplemental UNMC)

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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