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.

Condition	Treatment or Intervention	Phase
grade 1 follicular lymphoma grade 2 follicular lymphoma grade 3 follicular lymphoma	Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine  Drug: sargramostim  Procedure: biological response modifier therapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: tumor cell derivative vaccine  Procedure: vaccine therapy	Phase II

Further Study Details: 

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 conjugate vaccine and sargramostim after rituximab (groups I and II).
• Determine the immune response rate in patients treated with these regimens (groups I, II, and III).
• Determine the safety and toxicity of these regimens in these patients (groups I, II, and III).

OUTLINE: This is an open-label, multicenter study for patients previously registered on and confirmed ineligible for randomization in protocol .

Patients receive rituximab IV weekly for 4 weeks.

• Group I: The first 30 patients to achieve and maintain a partial response (PR) or better receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously (SC) on day 1 and sargramostim SC on days 1-4 beginning 26 weeks after the last dose of rituximab. Treatment repeats every 2 weeks for 14 weeks (8 immunizations).
• Group II: All subsequent patients who achieve a PR or better receive autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC as in group I beginning 13 weeks after the last dose of rituximab.
• Group III: Patients who are not eligible for group I or II and, in the investigator's opinion, are suitable candidates for immunization with autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC receive the same treatment as groups I and II, beginning no more than 1 year after the last (fourth) dose of rituximab. In all groups, treatment continues in the absence of unacceptable toxicity or emergence of an illness that may interfere with study assessments.

Patients are followed for initial response 8 weeks after completion of immunizations and then every 12 weeks for an additional year. Thereafter, all immunized patients will be followed every 6 months until receipt of first subsequent anti-lymphoma therapy.

PROJECTED ACCRUAL: Up to 120 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed follicular center cell non-Hodgkin's lymphoma
• Stage III or IV disease at time of entry on
• 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 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
• 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

California
      Stanford Cancer Center at Stanford University Medical Center, Stanford,  California,  94305-5151,  United States; Recruiting
Illinois
      Rush Cancer Institute at Rush University Medical Center, Chicago,  Illinois,  60612,  United States; Recruiting
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States; Recruiting
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States; Recruiting
Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
Missouri
      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
Nebraska
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States; Recruiting
New York
      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States; Recruiting
Oregon
      Cancer Institute at Oregon Health and Science University, Portland,  Oregon,  97201-3098,  United States; Recruiting
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada; Recruiting
Canada, Ontario
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada; Recruiting

Study chairs or principal investigators

Kristy Kohli,  Study Chair,  Genitope   

Study ID Numbers:  CDR0000269810; GENITOPE-2002-09; IUMC-0212-20; NCT00071955
Record last reviewed:  March 2005
Last Updated:  April 5, 2005
Record first received:  November 4, 2003
ClinicalTrials.gov Identifier:  NCT00071955
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08