A Phase III Trial To Evaluate The Safety And Efficacy Of Specific Immunotherapy, Recombinant Idiotype Conjugated To KLH With GM-CSF, Compared To Non-Specific Immunotherapy, KLH With GM-CSF, In Patients With Follicular Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 47
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill cancer cells. It is not yet known which regimen of chemotherapy combined with vaccine therapy is more effective for non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Compare the time to tumor progression in patients with stage III or IV follicular B-cell non-Hodgkin's lymphoma treated with cyclophosphamide, prednisone, and vincristine followed by immunotherapy with keyhole limpet hemocyanin with or without autologous tumor-derived immunoglobulin idiotype and adjuvant sargramostim (GM-CSF).
- Compare the efficacy of these immunotherapy regimens in terms of converting patients with partial response or unconfirmed complete response to clinical complete response.
- Compare the safety and toxic effects of these immunotherapy regimens in this patient population.
- Compare the time to treatment failure and survival of patients treated with these regimens.
- Correlate the induction of idiotype-specific immune response with clinical benefits of achieving molecular remission in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
Patients receive cyclophosphamide IV over 30-40 minutes and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 8 courses.
At 6 months after completion of chemotherapy, patients maintaining partial response (PR), complete response (CR), or unconfirmed complete response (CRU) receive immunotherapy. Patients are stratified according to participating center and baseline disease status (PR vs CR/CRU). Patients are randomized to one of two treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage III or IV follicular B-cell non-Hodgkin's lymphoma
- •At least 1 bidimensionally measurable lesion by radiography, in addition to lesion removed for biopsy
- •No clinical evidence of CNS involvement
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •Creatinine less than 1.5 times ULN
- •No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
- •No history of autoimmune disease
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior antibody therapy for lymphoma
- •Chemotherapy:
- •No prior cytotoxic therapy for lymphoma
- •Endocrine therapy:
- •No prior corticosteroids for lymphoma
- •At least 12 months since prior corticosteroids or immunosuppressants for other conditions
- •Prior transient corticosteroids (prior to CT imaging) or optical solutions allowed
- •Radiotherapy:
- •Prior radiotherapy for lymphoma (no more than 2 sites of limited disease) allowed
- •See Disease Characteristics
- •No concurrent participation in other therapeutic clinical trial
排除标准
- 未提供