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

July 31, 2007
March 14, 2008
May 2007
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Complete list of historical versions of study NCT00510471 on ClinicalTrials.gov Archive Site
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Personalized Active Immunotherapy (Vaccine Therapy) and Sargramostim Given After Standard of Care Treatment With Rituximab and Chemotherapy for Initial Treatment With Lymphoma
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)

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.

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Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Non-Hodgkin's Lymphoma
Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00510471
2007-12
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Genitope Corporation
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Genitope Corporation
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP