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-9407 NCI-V94-0576

Objectives

I.  Assess the evaluable and/or objective response rate to ImmTher with vs. 
without indomethacin in patients with prostate cancer metastatic predominantly 
to the bone.

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:

Prostate cancer that is metastatic predominantly to the bone

Failure on initial hormonal management required

PSA at least 3 x normal

Prior/Concurrent Therapy:

No more than 2 prior regimens (hormonal, chemotherapy, radiotherapy, or a
combination) following failure on initial hormonal therapy

At least 2 weeks since prior therapy (4 weeks since flutamide)

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:
  Karnofsky 60-100%

Life expectancy:
  At least 6 months

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

Hepatic:
  Bilirubin normal
  LDH no greater than 2 x normal

Renal:
  Creatinine normal

Cardiovascular:
  NYHA class I status
  No active ischemic heart disease
  No thromboembolic disease

Pulmonary:
  pO2 at least 75 mm Hg
  pCO2 23-48 mm Hg
  DLCO at least 60% of normal
  No asthma
  No bronchospasm
  No other significant pulmonary disease

Other:
  No autoimmune and/or collagen-vascular disease
  No active, severe infection
  No history of significant gastric/duodenal ulcer
  No senility or severe emotional instability
  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