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

This study has been terminated.
Sponsor:
Information provided by:
Genitope Corporation
ClinicalTrials.gov Identifier:
NCT00510471
First received: July 31, 2007
Last updated: March 14, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Genitope Corporation:

Study Start Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510471

Locations
United States, California
Keck School of Medicine of University Southern California
Los Angeles, California, United States, 90089
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, New York
Weill Medical College of Cornell University, NY Presbyterian Hospital
New York, New York, United States, 10021
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73174
United States, Oregon
Providence Portland Cancer Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Genitope Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00510471     History of Changes
Other Study ID Numbers: 2007-12
Study First Received: July 31, 2007
Last Updated: March 14, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunoglobulin Idiotypes
Immunoglobulins
Antibodies
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014