Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	Pharmaceutical / Industry	SPRI-C94-049 SCH-C94-049-01, NCI-V95-0654

Objectives

I.  Determine time to progression or relapse in patients with locally 
advanced, unresectable Stage IIIA/B non-small cell lung cancer (NSCLC) that is 
in clinical complete remission, partial remission, or is stable following 
combined modality therapy (chemotherapy with either radiotherapy or surgery or 
both), chemotherapy alone, or radiotherapy alone treated with 2 or 4 
micrograms/kg interleukin-4 (IL-4) vs. placebo.

II.  Evaluate the impact of these 2 doses of IL-4 on overall survival.

III.  Characterize the safety of and tolerance to these 2 doses of IL-4 given 
3 times weekly to patients with NSCLC.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed non-small cell lung cancer
  Clinical complete remission, partial remission, minimal residual disease, or
  stable disease during and following induction

  No interval progression

  Cytologic specimens obtained by brushing, washing, or needle aspiration of
  defined lesion acceptable
     Sputum cytology confirmed by study pathologist

Mixed tumors categorized by predominant cell type
  No small cell anaplastic elements

Unresectable Stage IIIA (T1-2 N2, T3 N0-2, Tx N2) or Stage IIIB (T1-3 N3, T4
N0-2) disease
  Staging for entry considered initial staging prior to any primary therapy

  Histologic confirmation of nodal involvement required if bidimensionally
  measured lymph node less than 2 cm (strongly recommended for nodes 2 cm or
  more)

  No medically inoperable Stage I/II disease

No Stage IV or recurrent disease
  No bronchoalveolar cell carcinoma with multilobar involvement
  No past or present CNS metastases

No large malignant pleural effusion on chest x-ray

Prior/Concurrent Therapy:

Prior standard combination chemotherapy plus either radiotherapy or surgery
(or both), chemotherapy alone, or radiotherapy alone (Stage IIIA only)
required
  1 and only 1 prior chemotherapy regimen
     Multiple courses of the same combination chemotherapy regimen allowed
  Chemotherapy given either pre- or postoperatively
  Diagnostic biopsy not considered surgery
  30-90 days since completion of prior therapy and recovered

No prior immunotherapy

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0 or 1
  ECOG 2 if weight gain at least 5% between completion of therapy (or last
     available weight) and protocol treatment

Life expectancy:
  At least 12 weeks

Hematopoietic:
  ANC at least 1,500
  Platelets at least 130,000
  Hemoglobin at least 9 g/dL

Hepatic:
  Bilirubin no greater than 1.5 times normal
  AST or ALT no greater than 1.5 times normal

Renal:
  Creatinine normal OR
  Creatinine clearance (calculated) at least 60 mL/min

Cardiovascular:
  Left ventricular ejection fraction normal
  No myocardial infarction within 6 months
  No congestive heart failure
  No NYHA class 3/4 status
  No unstable angina
  No ventricular arrhythmia
  No ongoing atrial fibrillation (even if treated)

Other:
  No HIV antibody
  No HBsAg or hepatitis C antibody
  No active bleeding peptic ulcer within 6 months
  No insulin-dependent diabetes mellitus or requirement for oral hypoglycemics
     if glucose control is poor or insulin or other medication dose cannot be
     adjusted based on oral intake
  No known alcohol or drug abuse
  No active second malignancy that would be likely to cause death
  No pregnant or nursing women
  Effective contraception required of fertile women

Expected Enrollment

110 evaluable patients/arm will be studied in this multicenter (30-40 centers) 
trial.

Outline

Randomized, double-blind, placebo-controlled study.

Arm I:  Biological Response Modifier Therapy.  Interleukin-4 
(Schering-Plough), IL-4, NSC-618085.  Low Dose.

Arm II:  Biological Response Modifier Therapy.  IL-4.  High Dose.

Arm III:  Control.  Placebo, PLCB.

Trial Contact Information

Trial Lead Organizations

Schering-Plough Research Institute

Israel Wiznitzer, MD, Protocol chair(Contact information may not be current)		Ph: 847-480-3980 Email: iwiznitzer@pol.net