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

Sponsor

Genitope Corporation (Industry)

Overall Status

Terminated

CT.gov ID

NCT00510471

Collaborator

(none)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine	Phase 2

Study Design

Study Type:

Interventional

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

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)

Study Start Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keck School of Medicine of University Southern California	Los Angeles	California	United States	90089
2	Rocky Mountain Cancer Centers	Denver	Colorado	United States	80218
3	Indiana University Medical Center	Indianapolis	Indiana	United States	46202
4	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
5	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-7680
6	Weill Medical College of Cornell University, NY Presbyterian Hospital	New York	New York	United States	10021
7	Carolinas Medical Center	Charlotte	North Carolina	United States	28204
8	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma	United States	73174
9	Providence Portland Cancer Center	Portland	Oregon	United States	97213