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 Closed no age specified NBSG-9408 NCI-V94-0575

Objectives

I.  Assess the objective response rate to ImmTher with vs. without 
indomethacin in patients with colorectal cancer metastatic predominantly to 
the liver.

II.  Assess the duration of response to this treatment.

III.  Evaluate the effect of indomethacin on any observed biologic and 
clinical response.

Entry Criteria

Disease Characteristics:

Colorectal cancer that is metastatic predominantly to the liver
  Metastatic disease at initial diagnosis eligible following appropriate
  management of primary tumor

  Pathologic confirmation of metastatic liver lesion required if metastasis
  occurred more than 2 years following resection of the primary tumor
     Needle aspiration preferable

Measurable liver lesion required

Prior/Concurrent Therapy:

No more than 1 prior chemotherapy regimen for metastatic disease

At least 7 days since prednisone or other steroids, aspirin or aspirin-
containing drugs, or NSAIDs
  Acetaminophen with codeine or with oxycodone allowed

Patient Characteristics:

Age:
  Not specified

Performance status:
  ECOG 0-2 (Karnofsky 60-100%)

Hematopoietic:
  AGC at least 1,500
  Platelets at least 100,000
  Hb at least 9.0 g/dl

Hepatic:
  Bilirubin normal

Renal:
  Creatinine no greater than 2 x normal
  BUN no greater than 2 x normal

Cardiovascular:
  NYHA class I status
  No current ischemia
  No history of thrombotic disease

Pulmonary:
  pO2 at least 75 mm Hg
  pCO2 no greater than 23-48 mm Hg
  DLCO at least 60% of predicted
  No history of asthma
  No history of bronchospasm
  No other significant pulmonary disease

Other:
  No autoimmune and/or collagen-vascular disease
  No active severe infection
  No history of allergy
  No history of significant gastric/duodenal ulcer or other acid-peptic
     disease
  No senility or severe emotional instability
  No pregnant or nursing women
  Effective contraception required of fertile patients
  Able to cooperate with study

Blood/body fluid analyses to determine eligibility and imaging studies and
physical exams for tumor measurement completed within 14 days prior to entry

Expected Enrollment

15 patients/arm will be accrued; if a significant biologic or clinical 
difference is seen between these arms, 15 additional patients may be entered 
on the superior arm.

Outline

Randomized study.

Arm I:  Immune Modulator Therapy.  ImmTher, a lipophilic disaccharide 
dipeptide encapsulated in liposomes composed of phosphatidyl choline and 
phosphatidyl glycerol.

Arm II:  Immune Modulator Therapy with Prostaglandin Inhibition Therapy.  
ImmTher; with Indomethacin.

Trial Contact Information

Trial Lead Organizations

Cancer Biotherapy Research Group

Tracy Dobbs, MD, Protocol chair		Ph: 949-760-5543