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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