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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
Sponsored by
Cancer Biotherapy Research Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bloomington Hospital
  • Bergan Mercy Medical Center
  • St. Joseph Regional Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
November 5, 2013
Sponsor
Cancer Biotherapy Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT00003090
Brief Title
Biological Therapy in Previously Treated Patients With Non-small Cell Lung Cancer
Official Title
Phase II Trial of Bolus Interleukin-2 in Previously Treated Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2000
Overall Recruitment Status
Unknown status
Study Start Date
January 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Biotherapy Research Group

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Datchen F. Tai, MD
Organizational Affiliation
Cancer Biotherapy Research Group
Official's Role
Study Chair
Facility Information:
Facility Name
Bloomington Hospital
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47402
Country
United States
Facility Name
Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
St. Joseph Regional Cancer Center
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States

12. IPD Sharing Statement

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

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