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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003090
First received: November 1, 1999
Last updated: November 5, 2013
Last verified: July 2000
  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
Biological: aldesleukin
Phase 2

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

Resource links provided by NLM:


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
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: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003090     History of Changes
Other Study ID Numbers: CDR0000065794, CBRG-9602, NBSG-9602, NCI-V97-1345
Study First Received: November 1, 1999
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Aldesleukin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 31, 2014