Status:
COMPLETED
Safety Study of a Cell Penetrating Peptide (p28) to Treat Solid Tumors That Resist Standard Methods of Treatment
Lead Sponsor:
Dr. Tapas K. Das Gupta
Conditions:
Refractory Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety of an experimental drug (p28) as a treatment for certain advanced cancers which express a protein called p53 and which have not responded to prior t...
Detailed Description
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 fro...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00914914
Start Date
April 1 2009
End Date
June 1 2011
Last Update
October 28 2014
Active Locations (1)
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1
University of Illinois at Chicago Department of Surgical Oncology
Chicago, Illinois, United States, 60612