Status:
COMPLETED
Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma
Lead Sponsor:
Genitope Corporation
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's...
Detailed Description
OBJECTIVES: * Determine progression-free survival in patients with refractory or progressive follicular non-Hodgkin's lymphoma treated with immediate or delayed autologous immunoglobulin idiotype-KLH...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed follicular center cell non-Hodgkin's lymphoma
- Stage III or IV disease at time of entry on Genitope-G2000-03
- At least 1 bidimensionally measurable lesion (1.5 cm X 1.5 cm) by radiography
- Previously registered on and confirmed to be ineligible for randomization on Genitope-G2000-03 by failing to achieve or maintain a complete or partial response after chemotherapy by CT scans of the chest, abdomen, and pelvis (and neck if there was palpable disease)
- Completed all 8 courses of chemotherapy (cyclophosphamide, vincristine, and prednisone \[CVP\]) per Genitope-G2000-03
- No intervening therapy for lymphoma (i.e., antibody, corticosteroids, or cytotoxic) between CVP and study entry
- No evidence of transformation (e.g., rapid tumor growth or increasing lactic dehydrogenase)
- No CNS involvement
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after the last immunization series
- HIV negative
- No history of autoimmune disease or conditions requiring treatment with immunosuppressive agents, including corticosteroids
- No other malignancy within the past 2 years except non-basal cell skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- See Disease Characteristics
- At least 6 months since prior corticosteroids, including topical administration for any concurrent disease
- No concurrent chronic (more than twice monthly) corticosteroids (including topical or inhaled)
- Transient use (prior to CT scan) or optical solutions allowed
- Radiotherapy
- Prior radiotherapy to no more than 2 sites more than 13 weeks before rituximab is allowed
- Surgery
- Not specified
- Other
- No concurrent participation in other therapeutic clinical trials
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00071955
Start Date
March 1 2003
End Date
January 1 2009
Last Update
December 19 2013
Active Locations (11)
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1
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305-5151
2
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, United States, 60612
3
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
4
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231