Vaccine Therapy and GM-CSF in Treating Patients With CNS Lymphoma

• Status: Withdrawn
• Trial end date: 2008-12-08
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Vaccines made from a person's cancer proteins may help 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. Giving vaccine therapy together with GM-CSF may make a stronger immune response and kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects and how well giving vaccine therapy together with GM-CSF works in treating patients with CNS lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Simmons Cancer Center; University of Texas Southwestern Medical Center
• Treatments: Antibodies; Immunoglobulin Idiotypes; Immunoglobulins; Immunoglobulins, Intravenous; Methotrexate; Sargramostim; Thiotepa; Vaccines

Criteria

DISEASE CHARACTERISTICS:

• Histologically or CSF cytologically confirmed CNS lymphoma with any of the following clinical histories:

• Primary CNS lymphoma at initial diagnosis

• Primary CNS lymphoma at relapse

• Systemic lymphoma with CNS disease at initial diagnosis or at relapse

• Adequate fresh tissue or cell pellet available for analysis by Genitope Corporation to determine adequacy for idiotype (Id) manufacturing

• Tumor must express both functional light and heavy chain genes

• No tumors known or found to be surface immunoglobulin negative

• Not in leukemic phase (i.e., > 5,000/mm³ circulating tumor cells)

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100%

• WBC ≥ 1,500/mm³

• Platelet count ≥ 75,000/mm³

• Hemoglobin ≥ 10 g/dL

• Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Gilbert's disease)

• Creatinine ≤ 1.5 times ULN

• Able to undergo placement of an Ommaya reservoir

• Able to receive induction therapy (chemotherapy with or without brain radiotherapy) with intent to induce remission

• Speaks English or Spanish

• No other malignancy within the past 3 years, except adequately treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ

• Not pregnant or nursing

• No immunosuppressive viral infections as evidenced by HIV antibody or antigen, hepatitis B antigen, or hepatitis C antibody or antigen positivity

• No history of autoimmune disease that required treatment within the past 5 years, including previously treated autoimmune hemolytic anemia or immune thrombocytopenia

PRIOR CONCURRENT THERAPY:

• More than 30 days since prior and no concurrent participation in another therapeutic clinical trial

• More than 2 weeks since prior steroids

• No concurrent immunosuppressives, including corticosteroids

• Transient use of optical or nasal steroid solutions is allowed

• No other concurrent anticancer therapy or therapy for non-Hodgkin lymphoma