Status:
WITHDRAWN
Vaccine Therapy and GM-CSF in Treating Patients With CNS Lymphoma
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Brain and Central Nervous System Tumors
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * To determine the proportion of patients with CNS lymphoma who develop anti-idiotype (Id) and anti-keyhole limpet hemocyanin (KLH) humoral immune responses in the serum and/or C...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 19 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00621036
Start Date
October 19 2007
End Date
December 8 2008
Last Update
November 26 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390