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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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 treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Tapas K. Das Gupta

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).