S0122: Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Southwest Oncology Group
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:	Masking: Open Label Primary Purpose: Treatment
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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Etoposide phosphate Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

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

Show 100 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Abdul-Rahman Jazieh, MD, MPH

Barrett Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Laurence H. Baker, Southwest Oncology Group - Group Chair's Office
ClinicalTrials.gov Identifier:	NCT00045617 History of Changes
Other Study ID Numbers:	CDR0000256922, SWOG-S0122
Study First Received:	September 6, 2002
Last Updated:	July 18, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:

limited stage small cell lung cancer

Additional relevant MeSH terms:

Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies
Immunoglobulins

Antibodies, Monoclonal
Immunoglobulin Idiotypes
Etoposide phosphate
Cisplatin
Etoposide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 12, 2012