Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's Lymphoma

Not Recruiting

Trial ID: NCT00104819


RATIONALE: Vaccines made from a person's cancer cells may make the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may stimulate the immune system in different ways and stop cancer cells from growing. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkin's lymphoma.

Official Title

Phase II Trial of FavId™ (Patient-Specific Idiotype/KLH) and GM-CSF in Subjects Who Demonstrated Progressive Disease and Did Not Receive FavId on Study FavId-06

Stanford Investigator(s)

Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology



   - Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)

      - Grade 1, 2, or 3

   - Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH
   conjugate vaccine (FavId™) while enrolled on protocol FAV-ID-06

   - Meets 1 of the following criteria:

      - Received salvage therapy after completion of protocol FAV-ID-06

         - At least 4 weeks, but no more than 4 months, since prior salvage therapy

      - Did not receive salvage therapy after completion of protocol FAV-ID-06

         - At least 4 weeks, but no more than 4 months, since completion of prior
         treatment on protocol FAV-ID-06

   - No history of CNS lymphoma OR meningeal lymphomatosis



   - 18 and over

Performance status

   - ECOG 0-2

Life expectancy

   - Not specified


   - Not specified


   - Not specified


   - Not specified


   - No history of congestive heart failure


   - No history of compromised pulmonary function


   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective contraception

   - HIV negative

   - No active bacterial, viral, or fungal infection

   - No psychiatric disorder

   - No other serious nonmalignant disease that would preclude study participation


Biologic therapy

   - See Disease Characteristics

   - No prior allogeneic transplantation*

   - No prior rituximab regimen* other than that administered on protocol FAV-ID-06
   (rituximab 375 mg/m^2 IV weekly for 4 weeks)


   - No prior purine analogues* (e.g., fludarabine or cladribine)

Endocrine therapy

   - No prior or concurrent steroids (e.g., steroid doses in excess of daily replacement)


   - Not specified


   - Not specified


   - Recovered from prior salvage therapy

   - No prior or concurrent immunosuppressive therapy

   - No prior investigational agents*

   - No other concurrent antilymphoma therapy NOTE: *As salvage therapy administered
   between completion of protocol FAV-ID-06 and enrollment onto this study


biological: autologous immunoglobulin idiotype-KLH conjugate vaccine

biological: sargramostim

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mayita Romero

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