S0122: Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Limited-Stage Small Cell Lung Cancer

This study has been terminated.
(Closed due to lack of drug availability.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00045617
First received: September 6, 2002
Last updated: June 11, 2012
Last verified: June 2012
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
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:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • overall survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    time from date of registration to date of death


Secondary Outcome Measures:
  • immune response [ Time Frame: at Week 10 ] [ Designated as safety issue: No ]
    T-cell proliferation and HAMA testing

  • toxicity assessment [ Time Frame: 22 weeks ] [ Designated as safety issue: Yes ]
    assessment of qualitative and quantitative toxicities

  • response [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
    RECIST partial and complete response


Enrollment: 9
Study Start Date: January 2003
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Biological: monoclonal antibody 11D10 anti-idiotype vaccine Biological: monoclonal antibody GD2 anti-idiotype vaccine Drug: cisplatin Drug: etoposide Radiation: radiation therapy

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 100 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Abdul-Rahman Jazieh, MD, MPH Barrett Cancer Center
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00045617     History of Changes
Other Study ID Numbers: CDR0000256922, S0122, U10CA032102
Study First Received: September 6, 2002
Last Updated: June 11, 2012
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 July 24, 2014