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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

A Phase 2 Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With Follicular Non-Hodgkin's Lymphoma (fNHL) Following Primary Treatment With Rituximab and Chemotherapy (R-Chemo)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00510471
• Other study ID #: 2007-12
• 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
• 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

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,