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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 21 and over TCSC-P-30-PROTEIN NCI-V90-0188

Objectives

I.  Determine the toxicity and potential biological effects of single 
intravenous doses of P-30 protein administered weekly in patients with 
malignant disease.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 21 years of age 
with histologically confirmed malignancy other than lymphoma or leukemia who 
have failed appropriate conventional therapy; patients who refuse conventional 
therapy are not eligible.  Measurable disease is desired but not required.  
There must have been no prior therapy with biological response modifiers 
including interferons, interleukins, and tumor necrosis factor.  At least 4 
weeks must have elapsed since prior surgery, radiotherapy, or chemotherapy (6 
weeks for mitomycin or nitrosoureas), and patients must have recovered from 
the toxic effects of prior therapy (no toxicity greater than grade I).  
Patients with potentially hormone-responsive malignancies such as breast or 
prostate carcinoma must be off hormonal therapy at least 3 days prior to 
initiation of protocol therapy (these patients are evaluable for toxicity but 
not for response).  An ECOG performance status of 0 or 1 (Karnofsky 80-100%) 
and a life expectancy of at least 3 months are required, as is adequate organ 
function demonstrated as follows:  WBC at least 3,500, platelets at least 
100,000, creatinine no more than 2 x the upper limit of normal, and SGOT and 
bilirubin no more than 2 x the upper limits of normal.  Patients with 
symptomatic cardiovascular disease (i.e., NYHA class II-IV disease), 
congestive heart failure, angina pectoris, arrhythmia, and uncontrolled 
hypertension are ineligible.  Serious active infections must be resolved prior 
to entry, and patients must be HBsAg negative.  The following conditions also 
exclude:  a requirement for systemic corticosteroids; psychiatric disorder or 
neurologic disease including brain metastases, seizure disorders, and 
leptomeningeal disease; prior organ allograft; significant metabolic 
abnormalities including uncontrolled diabetes mellitus, significant 
electrolyte abnormalities, and any degree of metabolic acidosis; any 
hemostasis impairment such as bleeding disorder or coagulation abnormality; 
and severe anorexia or grade III/IV nausea or vomiting.  Patients who cannot 
cooperate because of senility or emotional instability are ineligible.  
Fertile women must use effective contraceptives; pregnant and lactating women 
are ineligible.

Expected Enrollment

3-5 patients will be entered at each dose studied.

Outline

Nonrandomized study.

Single-Agent Chemotherapy.  P-30 Protein.

Trial Contact Information

Trial Lead Organizations

Thompson Cancer Survival Center

John Costanzi, MD, Protocol chair		Ph: 512-343-2103 Email: drjjjc@aol.com