Completed

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

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What is being tested

autologous immunoglobulin idiotype-KLH conjugate vaccine

+ sargramostim
Biological
Who is being recruted

Lymphoma

Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2003

Summary

Principal SponsorGenitope Corporation
Last updated: December 19, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitleA 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 
Principal SponsorGenitope Corporation
Last updated: December 19, 2013
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.
Design Details
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.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lymphoma
Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


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 11 locations
Suspended
Stanford Cancer Center at Stanford University Medical CenterStanford, United StatesSee the location
Suspended
Rush Cancer Institute at Rush University Medical CenterChicago, United States
Suspended
Indiana University Cancer CenterIndianapolis, United States
Suspended
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, United States

Completed11 Study Centers