Oncoquest-L Vaccine in Patients With Previously Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Overall tumor response rate
研究概览
简要总结
This Phase II trial studies the overall tumor response of vaccine therapy in patientswith previously untreated Stage III or IV, asymptomatic, non-bulky follicular lymphoma. The vaccine contains an extract of the patient's own cancer cells and the immunostimulant protein, interleukin-2 (IL-2). It is hoped that when injected under the skin, the vaccine will enable the patient's immune system to recognize and destroy the cancer cells. The trial will also assess the safety of the vaccine, the time from vaccine treatment until the patient requires another type of anti-lymphoma treatment, progression-free survival, and the anti-tumor immune response.
详细描述
This is a single-arm open-label pilot Phase II study. Following informed consent, eligible subjects will undergo excisional biopsy of a lymphoma-containing lymph node for diagnosis and for generation of the Oncoquest-L vaccine. Patients will receive subcutaneous injections consisting of their autologous tumor-derived Oncoquest-L vaccine starting at approximately 4 to 8 weeks after the biopsy. The first two doses will be given at a 2-week interval and the remaining 3 doses at monthly intervals. Patients will be monitored for response by performing imaging studies at baseline and 1 month after the fifth vaccination (Week 19). Additional imaging studies will be performed every 3 months for the first year and every 6 months during the second year until relapse or disease progression whichever occurs sooner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Follicular lymphoma (FL) grade 1, 2, or 3a diagnosed within 12 months of study enrollment
- •Age ≥ 18 years
- •Previously untreated Stage III or IV FL
- •A single peripheral lymph node of at least 1 x 1 cm in size accessible for excisional biopsy
- •Measurable or evaluable disease after obtaining tissue for vaccine production
- •Performance status (ECOG) of 0 or 1
- •Asymptomatic disease without B symptoms or severe pruritus
- •Low tumor burden as defined by the following criteria:
- •Normal lactic dehydrogenase
- •Largest tumor mass < 7 cm
- •Involvement of < 3 nodal sites with a diameter ≥ 3 cm
- •No clinically significant pleural effusion or ascites
- •Spleen size of ≤ 16 cm by CT scan
- •Circulating tumor cells < 5.0 x 109/L
- •No clinically significant organ compression
- •Adequate hematopoietic parameters:
- •Absolute neutrophil count ≥ 1.5 x 109/L
- •Platelet count ≥ 100 x 109/L
- •Hemoglobin ≥ 10 g/dL
- •Serum creatinine ≤ 2 x upper limit of normal (ULN)
- •Total bilirubin ≤ 2 x ULN unless considered secondary to Gilbert's syndrome. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase ≤ 2 x ULN
- •Fertile patients must use effective contraception during and for 12 months after completion of therapy
- •For fertile female patients, a negative pregnancy test result at enrollment
排除标准
- •Active HIV, hepatitis B, hepatitis C or other active infectious process
- •Pregnant or nursing women
- •Patients with previous history of malignancy within the past 2 years except curatively treated squamous or basal cell carcinoma of the skin or curatively treated carcinoma in situ of the cervix.
- •Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment
- •Concurrent treatment with immunosuppressive therapy
结局指标
主要结局
Overall tumor response rate
时间窗: Up to 2 years
Tumor measurements will be performed at enrollment (baseline); then, tumor measurements and response assessments will occur 4 weeks after the 5th vaccination. Thereafter, tumor measurements and response assessments will occur every 3 months during the 1st year and then every 6 months during the 2nd year until relapse or disease progression, whichever occurs first.
次要结局
- Assessment of complete and partial tumor response rates(Up to 2 years)
- Assessment of time until initiation of radiotherapy or systemic therapy(Up to 2 years)
- Safety evaluation will include frequency, severity, and relationship of adverse events to vaccination; vital signs (blood pressure, respiration, pulse, and temperature); and laboratory test results (including, hematology and clinical chemistry)(From the time of informed consent up to 2 years)
- Tests to measure tumor-specific antibody production and T cell and B cell responses to vaccination(From 8 weeks prior to the 1st vaccination to Week 19 following the 1st vaccination.)