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Biological Therapy in Previously Treated Patients With Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: Cancer Biotherapy Research Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003090
  Purpose

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill non-small cell lung cancer cells.

PURPOSE: Phase II trial to study the effect of biological therapy with interleukin-2 in patients with previously treated non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: aldesleukin
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   Aldesleukin    Interleukin-2   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Trial of Bolus Interleukin-2 in Previously Treated Lung Cancer

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

Estimated Enrollment:   30
Study Start Date:   January 1996

Detailed Description:

OBJECTIVES: I. Determine the response rate and median duration of response of interleukin-2 (IL-2) in patients with previously treated non-small cell lung cancer. II. Determine the median survival of patients treated with IL-2. III. Further delineate the toxicity of IL-2 in these patients.

OUTLINE: This is an open label study. Patients receive bolus interleukin-2 on days 1-5 and 8-12. The cycle repeats every 3 weeks. Patient response is evaluated after 2 cycles. Patients with stable disease, partial, or complete response may be treated with maintenance IL-2 for up to 4 additional cycles. Patient evaluation is performed after every 2 cycles. At this point, patients with stable or responding disease may be treated with IL-2 every 6 weeks until disease progression, intolerable toxic effects, or 2 cycles beyond complete response.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory non-small cell lung cancer At least one prior systemic therapy OR prior radiation therapy Must have measurable disease Previously irradiated sites of disease are not considered evaluable unless there is radiologic documentation of progression

PATIENT CHARACTERISTICS: Age: Not specified Performance Status: ECOG 0-2 Life Expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Hemoglobin greater than 10 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No prior history of myocardial infarction within previous 6 months No uncompensated congestive heart failure No primary (not due to electrolytes or drugs) cardiac arrhythmias besides premature ventricular contractions Pulmonary: No dyspnea at rest or need for supplemental oxygen Patients with symptomatic lung disease or extensive lung metastases must have oxygen saturation greater than 90% Other: Not pregnant or nursing Negative pregnancy test Patients with elevated temperatures greater than 100.5 F must have no occult infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent cyclosporin Chemotherapy: At least 3 weeks since chemotherapy and recovered No concurrent methotrexate See Disease Characteristics Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 3 weeks since radiotherapy See Disease Characteristics Surgery: Not specified

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003090

Locations
United States, Indiana
Bloomington Hospital    
      Bloomington, Indiana, United States, 47402
United States, Nebraska
Bergan Mercy Medical Center    
      Omaha, Nebraska, United States, 68124
United States, Texas
St. Joseph Regional Cancer Center    
      Bryan, Texas, United States, 77802

Sponsors and Collaborators
Cancer Biotherapy Research Group

Investigators
Study Chair:     Datchen F. Tai, MD     Cancer Biotherapy Research Group    
  More Information


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

Study ID Numbers:   CDR0000065794, CBRG-9602, NBSG-9602, NCI-V97-1345
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003090
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Aldesleukin
Respiratory Tract Diseases
Interleukin-2
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Anti-Infective Agents
Respiratory Tract Neoplasms
Neoplasms
Anti-HIV Agents
Neoplasms by Site
Neoplasms by Histologic Type
Anti-Retroviral Agents
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008




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