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Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: September 6, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045617
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: monoclonal antibody 11D10 anti-idiotype vaccine
Biological: monoclonal antibody GD2 anti-idiotype vaccine
Drug: cisplatin
Drug: etoposide
Radiation: radiation therapy
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045617

  Hide Study Locations
Locations
United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States, 85012
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States, 72205
United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States, 90073
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
University of Colorado Health Science Center
Aurora, Colorado, United States, 80010-0510
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, District of Columbia
MBCCOP - Howard University Cancer Center
Washington, District of Columbia, United States, 20060
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905-5650
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813-2424
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859-5000
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Loyola University Medical Center
Maywood, Illinois, United States, 60153-5500
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7323
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-W227
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States, 60141
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7353
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40502-2236
United States, Louisiana
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71130
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0912
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Providence Hospital - Southfield
Southfield, Michigan, United States, 48075-9975
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States, 48105
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
United States, Mississippi
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States, 39531-2410
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States, 39216
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States, 87108-5138
United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14642
Veterans Affairs Medical Center - Albany
Albany, New York, United States, 12208
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Dayton
Kettering, Ohio, United States, 45429
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-9001
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
Barrett Cancer Center
Cincinnati, Ohio, United States, 45267-0501
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97225
Oregon Cancer Institute
Portland, Oregon, United States, 97239
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97207
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States, 29401-5799
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234-6200
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4095
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7845
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
Veterans Affairs Medical Center - Houston
Houston, Texas, United States, 77030
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78284
Veterans Affairs Medical Center - Temple
Temple, Texas, United States, 76504
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5000
University of Washington School of Medicine
Seattle, Washington, United States, 98195-6527
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Abdul-Rahman Jazieh, MD, MPH Barrett Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000256922, SWOG-S0122
Study First Received: September 6, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00045617     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
limited stage small cell lung cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Immunoglobulin Idiotypes
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Etoposide phosphate
Antibodies, Monoclonal
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Etoposide
Immunoglobulins
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Antibodies
Radiation-Sensitizing Agents
Lung Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009