Personalized Active Immunotherapy (Vaccine Therapy) and Sargramostim Given After Standard of Care Treatment With Rituximab and Chemotherapy for Initial Treatment With Lymphoma

NCT ID: NCT00510471

Last Updated: 2008-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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The treatment being investigated is a patient- and tumor-specific therapy known as a personalized active immunotherapy. Personalized active immunotherapy is an attempt to use a person's own immune system to combat disease. Sargramostim (a.k.a. GM-CSF) is given together with the personalized active immunotherapy because it may increase the immune system's response and, therefore, aid in the effect of the personalized active immunotherapy.

This approach has previously been studied in patients with follicular Non-Hodgkin's lymphoma and other B-cell malignancies. Encouraging efficacy results and a favorable safety profile have been seen to date in these studies.

Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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autologous immunoglobulin idiotype-KLH conjugate vaccine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent
2. Previously untreated follicular NHL
3. Stage III or IV disease requiring treatment
4. Able to receive rituximab and chemotherapy (rituximab with cyclophosphamide, vincristine, and prednisone either with or without doxorubicin)
5. Able to provide tumor sample adequate for Id-KLH manufacture
6. ≥ 18 years of age
7. At least one bi-dimensionally measurable lesion ≥ 2 cm by CT scan
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genitope Corporation

INDUSTRY

Sponsor Role lead

Locations

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Keck School of Medicine of University Southern California

Los Angeles, California, United States

Site Status

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status

Indiana University Medical Center

Indianapolis, Indiana, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Weill Medical College of Cornell University, NY Presbyterian Hospital

New York, New York, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States

Site Status

Providence Portland Cancer Center

Portland, Oregon, United States

Site Status

Countries

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United States

Related Links

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http://www.genitope.com/

Click here for more information for untreated patients with follicular Non-Hodgkin's lymphoma who require treatment

Other Identifiers

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2007-12

Identifier Type: -

Identifier Source: org_study_id