Completed

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

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What is being tested

keyhole limpet hemocyanin

+ sargramostim

+ tumor cell-based vaccine therapy

Biological
Who is being recruted

Hemic and Lymphatic Diseases+7

+ Immune System Diseases

+ Immunoproliferative Disorders

From 18 to 120 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 1999
See protocol details

Summary

Principal SponsorUniversity of Nebraska
Last updated: December 27, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: June 25, 1999

Actual date on which the first participant was enrolled.

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 stage III or IV indolent 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 oral cyclophosphamide, vincristine, and prednisone (CVP). 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 10 courses. Patients not achieving adequate response receive up to 6 courses of alternate chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, and prednisone. At 3 months or up to 1 year 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) at 2 sites immediately followed by sargramostim (GM-CSF) SQ on day 1. Patients receive GM-CSF alone on days 2-4. Vaccination repeats every 4 weeks for 4 doses, followed 12 weeks 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.

NCT00004198
Principal SponsorUniversity of Nebraska
Last updated: December 27, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphomaLymphoma, Follicular

Criteria

15 inclusion criteria required to participate
Tumor sample safely accessible by biopsy, needle aspiration, or phlebotomy

Over 18 years old

Hemoglobin at least 10 g/dL

Must have adequate circulating lymphoma cells

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10 exclusion criteria prevent from participating
No prior cytotoxic therapy for lymphoma

No concurrent maintenance steroids or greater than 5 mg of daily prednisone or equivalent

No other malignancy within the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

No prior steroids for lymphoma

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Nebraska Medical Center

Omaha, United StatesOpen University of Nebraska Medical Center in Google Maps
CompletedOne Study Center