- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00045617
S0122: Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Limited-Stage Small Cell Lung Cancer
A Phase II Trial of Patients With Limited Stage Small Cell Lung Cancer Treated With Thoracic Radiation Therapy and Chemotherapy With Cisplatin/Etoposide Followed by Cisplatin/Etoposide and Anti-Idiotype Monoclonal Antibody Vaccines
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Vaccines may make the body build an immune response to kill tumor cells. Combining chemotherapy and radiation therapy with vaccine therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with vaccine therapy in treating patients who have limited-stage small cell lung cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine the efficacy of cisplatin, etoposide, and thoracic radiotherapy followed by cisplatin, etoposide, monoclonal antibody 11D10 anti-idiotype vaccine (TriAb), and monoclonal antibody GD2 anti-idiotype vaccine (TriGem), in terms of overall and progression-free survival of patients with limited stage small cell lung cancer.
- Determine the immune response to each of the 2 anti-idiotype vaccines when used in this regimen in these patients.
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Determine the response rates (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Thoracic radiotherapy is administered 5 days a week, beginning on day 1 of chemotherapy, for 5 weeks. Patients then undergo radiotherapy boost for 1.5 weeks.
Patients with stable disease or at least partial response proceed to consolidation therapy.
- Consolidation therapy (begins within 3-5 weeks of the last dose of induction chemotherapy or radiotherapy): Patients receive cisplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14. Patients also receive monoclonal antibody 11D10 anti-idiotype vaccine (TriAb) and monoclonal antibody GD2 anti-idiotype vaccine (TriGem) intradermally on day 1 of weeks 11, 13, 15, and 17 (4 injections) and then monthly subcutaneously for 2 years. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients who achieve complete response after consolidation chemotherapy undergo cranial radiotherapy 5 days a week for 3 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- British Columbia Cancer Agency
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Alabama
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Mobile, Alabama, United States, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, United States, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, United States, 85012
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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Tucson, Arizona, United States, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, United States, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, United States, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, United States, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, United States, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, United States, 95817
- University of California Davis Cancer Center
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Santa Rosa, California, United States, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, United States, 94535
- David Grant Medical Center
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Colorado
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Aurora, Colorado, United States, 80010-0510
- University of Colorado Health Science Center
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Denver, Colorado, United States, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, United States, 80010
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, United States, 20060
- MBCCOP - Howard University Cancer Center
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Georgia
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Atlanta, Georgia, United States, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, United States, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, United States, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, United States, 96813-2424
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, United States, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, United States, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, United States, 60611-W227
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Hines, Illinois, United States, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, United States, 60153-5500
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, United States, 66160-7353
- University of Kansas Medical Center
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, United States, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, United States, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, United States, 40502-2236
- Veterans Affairs Medical Center - Lexington
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, United States, 70112
- Veterans Affairs Medical Center - New Orleans
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Shreveport, Louisiana, United States, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, United States, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, United States, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, United States, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, United States, 48106
- CCOP - Ann Arbor Regional
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Ann Arbor, Michigan, United States, 48109-0912
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, United States, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, United States, 49503
- CCOP - Grand Rapids
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Royal Oak, Michigan, United States, 48073-6769
- CCOP - Beaumont
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Southfield, Michigan, United States, 48075-9975
- Providence Hospital - Southfield
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Mississippi
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Biloxi, Mississippi, United States, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, United States, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, United States, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, United States, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, United States, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, United States, 63110
- St. Louis University Health Sciences Center
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Springfield, Missouri, United States, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, United States, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, United States, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany, New York, United States, 12208
- Veterans Affairs Medical Center - Albany
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New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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North Carolina
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Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, United States, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, United States, 45267-0501
- Barrett Cancer Center
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Cleveland, Ohio, United States, 44195-9001
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, United States, 43206
- CCOP - Columbus
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Dayton, Ohio, United States, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, United States, 45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, United States, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, United States, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, United States, 97225
- CCOP - Columbia River Program
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Portland, Oregon, United States, 97239
- Oregon Cancer Institute
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South Carolina
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Charleston, South Carolina, United States, 29425-0721
- Medical University of South Carolina
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Charleston, South Carolina, United States, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, United States, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, United States, 78234-6200
- Brooke Army Medical Center
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Galveston, Texas, United States, 77555-0565
- University of Texas Medical Branch
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Houston, Texas, United States, 77030
- Veterans Affairs Medical Center - Houston
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Houston, Texas, United States, 77030-4095
- University of Texas - MD Anderson Cancer Center
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San Antonio, Texas, United States, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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San Antonio, Texas, United States, 78284-7845
- University of Texas Health Science Center at San Antonio
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Temple, Texas, United States, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, United States, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, United States, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, United States, 98108
- Veterans Affairs Medical Center - Seattle
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Seattle, Washington, United States, 98195-6527
- University of Washington School of Medicine
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Tacoma, Washington, United States, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC)
- Evidence of disease by CT scan of the chest
- Measurable or evaluable disease outside of area of prior surgical resection
- No malignant pericardial or pleural effusions (cytologically positive effusions or exudative effusions not attributable to other etiologies)
- No CNS disease by chest CT scan or MRI
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Not specified
Renal
- Creatinine no greater than upper limit of normal OR
- Creatinine clearance at least 60 mL/min
Other
- No prior hypersensitivity or contraindication to monoclonal antibody 11D10 anti-idiotype vaccine (TriAb), monoclonal antibody GD2 anti-idiotype vaccine (TriGem), or aluminum hydroxide
- No known sensitivity to rodent proteins (i.e., anti-OKT-3, ONCOSCINT scan)
- No grade 1 or greater symptomatic sensory neuropathy
- No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer in complete remission, or any other cancer for which patient has been disease free for 5 years
- If significant clinical hearing loss already present, must accept risk of further hearing loss
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy for SCLC
- No prior TriAb or TriGem
- No prior murine antibodies
- No prior mouse proteins
- At least 30 days since prior immunotherapy
- At least 30 days since any prior immunization
Chemotherapy
- No prior systemic chemotherapy for SCLC
- No concurrent cyclophosphamide or methotrexate
Endocrine therapy
- At least 30 days since prior systemic corticosteroids
- No concurrent systemic corticosteroids (except as an antiemetic)
Radiotherapy
- No prior radiotherapy to the thorax or neck region
- No concurrent intensity modulated radiotherapy
Surgery
- See Disease Characteristics
- At least 2 weeks since prior thoracic or other major surgery and recovered
Other
- At least 30 days since prior investigational agents or devices
- No other concurrent investigational agents
- No other concurrent immunosuppressants (e.g., cyclosporine)
- No concurrent chronic systemic antihistamines
- No concurrent amifostine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cisplatin and etoposide followed by vaccine
standard chemotherapy with cisplatin and etoposide followed by cisplans and etoposide with an anti-idiotype monoclonal antibody vaccine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: up to 5 years
|
time from date of registration to date of death
|
up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
immune response
Time Frame: at Week 10
|
T-cell proliferation and HAMA testing
|
at Week 10
|
toxicity assessment
Time Frame: 22 weeks
|
assessment of qualitative and quantitative toxicities
|
22 weeks
|
response
Time Frame: 25 weeks
|
RECIST partial and complete response
|
25 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Abdul-Rahman Jazieh, MD, MPH, Barrett Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Etoposide
- Antibodies
- Vaccines
- Immunoglobulins
- Immunoglobulin Idiotypes
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
Other Study ID Numbers
- CDR0000256922
- U10CA032102 (U.S. NIH Grant/Contract)
- S0122 (Other Identifier: SWOG)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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