Safety Study of a Cell Penetrating Peptide (p28) to Treat Solid Tumors That Resist Standard Methods of Treatment

Launched by DR. TAPAS K. DAS GUPTA · Jun 4, 2009

Keywords

ClinConnect Summary

The drug used in this study is p28, a cancer cell killing peptide. A peptide is a compound made of amino acids, which are substances that the body uses to make protein. The p28 peptide was created from a protein called azurin. Azurin is created by a common disease-causing bacteria named Pseudomonas Aeruginosa. p28 is experimental and has not yet been tested in humans and has not been approved by the FDA for use in cancer subjects.

Up to 30 subjects may be enrolled in order to find 15 subjects who qualify for the study.

Subjects will be enrolled in groups of three, each starting at one of ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients must have histologically proven solid tumor disease with documentation of measurable metastatic disease as defined by RECIST.
• • The term refractory solid tumor signifies patients with metastatic solid tumors who have failed all standard therapy or for whom no standard therapy exists.
• • In patients with refractory solid tumors, a pretreatment biopsy (either of the original primary or metastatic deposit) must show p53 (wild-type and to an extent mutant) expression by means of immunocytochemistry.
• • Patients must have distant metastases or unresectable local disease, but a projected life expectancy of at least 6 months.
• • Patients must have signed an informed consent.
• • This study is confined to adults of both sexes, age 18 or older.
• • Patients must have no medical problems that would pose an undue risk or that would limit full compliance with the study.
• • A minimum of 4 weeks must have elapsed since the completion of prior therapy, including hormonal therapy, chemotherapy, radiation therapy, immunotherapy, oral tyrosine kinase inhibitors and monoclonal antibodies.
• * Adequate baseline organ function assessed by the following laboratory values within 30 days prior to study entry:
• • Granulocyte count \>1,500/mm3, hematocrit \>30%, and platelets \>100,000/mm3.
• • Calculated creatinine clearance \>50ml/min.
• • Adequate liver function with SGOT, SGPT, LDH, and alkaline phosphatase \<3 x the upper limit of normal; serum bilirubin \<2.0 mg/dl.
• • PT and PTT not more than 1.5 times the upper limit of normal.
• • Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTs will be evaluated by a cardiologist or pulmonary physician prior to enrollment of this protocol.
• Exclusion Criteria:
• • Patients who are undergoing chemotherapy or immunotherapy, i.e., cytokines
• • Patients with refractory solid tumors whose primary tumor or metastatic deposits do not express p53 (null) will not be eligible.
• • Patients with serious additional illness, including HIV, hepatitis, or untreated active infection.
• • Patients with any underlying conditions that would contraindicate therapy with the study agent.
• • Patients with a history of prior malignancy in the past five years other than the current problem for which he/she is being considered for this trial (patients with prior history of basal cell carcinoma or squamous cell skin cancer are eligible).
• • Patients with any other serious medical, i.e., cardiovascular, uncontrolled diabetes (insulin resistant), or psychiatric illness that would prevent informed consent will not be eligible to participate in the study.
• • Patients who are either pregnant or lactating (all patients of childbearing potential will receive a pregnancy test within 2 days of study initiation).
• • Brain Metastases, current or past (unless treated at least one year prior to enrollment).