Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma - Article
Clinical Trial: Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
This study is no longer recruiting patients.
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: Randomizedphase 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.
|Condition||Treatment or Intervention||Phase|
|stage III grade 1 follicular lymphoma |
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
| Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine |
Drug: keyhole limpet hemocyanin
Procedure: biological response modifier therapy
Procedure: colony-stimulating factor therapy
Procedure: cytokine therapy
Procedure: non-specific immune-modulator therapy
Procedure: tumor cell derivative vaccine
Procedure: vaccine therapy
|Phase III |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lymphatic Diseases; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Cyclophosphamide, Prednisone, and Vincristine Followed By Immunotherapy With Keyhole Limpet Hemocyanin With or Without Recombinant Autologous Tumor-Derived Immunoglobulin Idiotype and Adjuvant Sargramostim (GM-CSF) in Patients With Stage III or IV Follicular B-Cell Non-Hodgkin's Lymphoma
- 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.
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.
- Arm I: Patients receive autologous tumor-derived immunoglobulin idiotype conjugated to keyhole limpet hemocyanin (KLH) subcutaneously (SC) on day 1 and adjuvant sargramostim (GM-CSF) SC on days 1-4 of weeks 0, 4, 8, 12, 16, 20, and 24.
- Arm II: Patients receive KLH alone SC on day 1 and GM-CSF SC on days 1-4 of weeks 0, 4, 8, 12, 16, 20, and 24. Quality of life is assessed prior to first immunization, at 2-8 weeks after completion of immunizations, and then every 6 months for 30 months.
Patients are followed every 3 months for 1 year and then every 6 months thereafter. Patients also enroll in a long-term follow-up study for an additional 5 years.
PROJECTED ACCRUAL: A total of 360 patients (240 in arm I and 120 in arm II) will be accrued from the 480 patients biopsied for this study within 15-18 months.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- 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: Age:
- 18 and over
- ECOG 0-2
- Not specified
- 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
- 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
- See Disease Characteristics
California Cancer Care, Inc., Greenbrae, California, 94904, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, 94305-5151, United States
SuperGen, Incorporated, Dublin, California, 94568, United States
Rocky Mountain Cancer Centers - Midtown, Denver, Colorado, 80218, United States
Shands Cancer Center at the University of Florida Health Science Center, Gainesville, Florida, 32610-0277, United States
Mountain States Tumor Institute - Boise, Boise, Idaho, 83712, United States
Rush Cancer Institute at Rush University Medical Center, Chicago, Illinois, 60612, United States
Indiana University Cancer Center, Indianapolis, Indiana, 46202, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1009, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, 21201, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0942, United States
Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan, 48105-2399, United States
Washington University School of Medicine, Saint Louis, Missouri, 63110, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-7680, United States
Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States
New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, 43210-1240, United States
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97201-3098, United States
Sarah Cannon Cancer Center at Centennial Medical Center, Nashville, Tennessee, 37203, United States
Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada
Canada, British Columbia
British Columbia Cancer Agency, Vancouver, British Columbia, V5Z 4E6, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, M4N 3M5, Canada
Lori Kunkel, MD, Study Chair, Genitope
Record last reviewed: July 2004
Last Updated: October 13, 2004
Record first received: June 6, 2001
ClinicalTrials.gov Identifier: NCT00017290
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005
- Central Nervous System Lymphoma, Primary (National Cancer Institute)