Lymphoma Clinical Trial
Official title:
A Phase II Study to Evaluate Safety and Efficacy of Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH and GM-CSF Following the Anti-CD20 Antibody, Rituximab, in Previously Treated Patients With Follicular Non-Hodgkin's Lymphoma
Verified date | January 2006 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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 cancer cells may make the body build an immune response to kill cancer
cells. Colony-stimulating factors such as sargramostim may increase the number of immune
cells found in bone marrow or peripheral blood.
PURPOSE: Phase II trial to study the effectiveness of rituximab followed by vaccine therapy
and sargramostim in treating patients who have refractory or progressive non-Hodgkin's
lymphoma.
Status | Completed |
Enrollment | 0 |
Est. completion date | January 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute at University of Alberta | Edmonton | Alberta |
Canada | Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre | Toronto | Ontario |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Rush Cancer Institute at Rush University Medical Center | Chicago | Illinois |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | New York Weill Cornell Cancer Center at Cornell University | New York | New York |
United States | UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska |
United States | Cancer Institute at Oregon Health and Science University | Portland | Oregon |
United States | Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis | Missouri |
United States | Stanford Cancer Center at Stanford University Medical Center | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Genitope Corporation |
United States, Canada,
Timmerman JM, Vose JM, Czerwinski DK, Weng WK, Ingolia D, Mayo M, Denney DW, Levy R. Tumor-specific recombinant idiotype immunisation after chemotherapy as initial treatment for follicular non-Hodgkin lymphoma. Leuk Lymphoma. 2009 Jan;50(1):37-46. doi: 10 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival (PFS) in groups I and II and median PFS by Kaplan-Meier curves quarterly for 1 year and then twice a year after study completion | No | ||
Secondary | Immune response rates in patients who received at least 4 immunizations by anti-idiotype antibody and anti-KLH antibody assays during every other immunization, last immunization, 2 and 8 weeks post immunization, and then quarterly for 1 year | No | ||
Secondary | Clinical response in patients who received at least 1 immunization in groups I and II by modified Cheson criteria post-immunization and then every 6 months for 1 year | No | ||
Secondary | Safety at the start of immunization, every 8 weeks during immunization, 2 and 8 weeks post immunization, and then quarterly for 1 year | Yes |
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