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Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's Lymphoma
Not Recruiting
Trial ID: NCT00104819
Purpose
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
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Eligibility
DISEASE CHARACTERISTICS:
* 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
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No history of congestive heart failure
Pulmonary
* No history of compromised pulmonary function
Other
* 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
PRIOR CONCURRENT THERAPY:
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)
Chemotherapy
* 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)
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* 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
Intervention(s):
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
6507256452