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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00510471
Other study ID # 2007-12
Secondary ID
Status Terminated
Phase Phase 2
First received July 31, 2007
Last updated March 14, 2008
Start date May 2007

Study information

Verified date March 2008
Source Genitope Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label


Intervention

Drug:
autologous immunoglobulin idiotype-KLH conjugate vaccine


Locations

Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Carolinas Medical Center Charlotte North Carolina
United States Rocky Mountain Cancer Centers Denver Colorado
United States Indiana University Medical Center Indianapolis Indiana
United States Keck School of Medicine of University Southern California Los Angeles California
United States Weill Medical College of Cornell University, NY Presbyterian Hospital New York New York
United States University of Oklahoma Health Science Center Oklahoma City Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States Providence Portland Cancer Center Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Genitope Corporation

Country where clinical trial is conducted

United States, 

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