Status:
TERMINATED
Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's Lymphoma
Lead Sponsor:
Favrille
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
OBJECTIVES: Primary * Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ and sargramostim (GM-CSF) to patients with progressive grade 1, 2, or 3 follicular B-ce...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00104819
Start Date
September 1 2004
Last Update
August 2 2013
Active Locations (51)
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1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
3
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0960
4
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048