A Phase I, Open Label Study of MBP-426 Given by Intravenous Infusion in Patients with Advanced or Metastatic Solid Tumors (M05-10070)
The goal of this clinical research study is to find the highest tolerable dose of the new drug MBP-426 that can be given to patients with advanced cancers. Any side effects that may be caused by MBP-426 and how MBP-426 is absorbed, moved throughout, and excreted (removed) from the body will be studied. The effectiveness of MBP-426 on advanced solid tumors will also be studied.
Disease Group: Solid Tumors
Treatment Agent: MBP-426
Treatment Location: Independent Multicenter Arrangements
Estimatated Length of Stay in Houston: Hospitalization is not required
Return Visit: Patients will be asked to stay in the Houston area for the first cycle of treatment for patient safety. They will then return approximately every 21 days for evaluation and treatment
Home Care: Patients will have lab tests performed on day 7 and day 14. These may be done ;at a local laboratory. All other evaluations and treatments will be done at ;MDACC
Primary Objectives: To assess the toxicity and safety profile of MBP-426 including the determination of the MTD, DLT and recommended Phase II dose. To perform Pharmacokinetic (PK) analysis of MBP-426 given by intravenous infusion. Secondary Objective: To assess the antitumor activity of MBP-426 given by intravenous infusion. Exploratory Objective: To evaluate the correlation between antitumor activity and blood transferrin levels, iron saturation status, circulating tumor cells, and/or transferrin receptor expression in archived tumor material
IRB Review and Approval Date: 10/05/2005
Recruitment Status: Not Accepting
Projected Accrual: 30
1) Have pathologically-confirmed malignancy that is locally advanced or
metastatic solid tumor and is refractory to standard therapy or for
which conventional therapy is not reliably effective or no effective
therapy is available.
2) Be aged >/= 18 years.
3) Have an ECOG Performance Status of 0, 1 or 2.
4) Have adequate clinical laboratory values (i.e., absolute neutrophil count >/= 1.5x10^9/L, platelets >/= 100 x 10^9/L, plasma creatinine </= 1.5 x upper limit of normal (ULN) for the institution; creatinine clearance (calculated) > 60 mL/min (using the Cockcroft Gault equation); bilirubin </= 1.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) </= 2.5 x ULN; patients with known liver metastases may have up to 5 times ULN for AST and ALT levels).
5) Have the ability to cooperate with treatment and follow-up schedules.
6) A negative pregnancy test and using at least one form of contraception as approved by the Investigator prior to study entry if a female patient of childbearing potential or a male patient with a female partner of childbearing potential.
7) Patients may have measurable disease as defined by RECIST criteria or non-measurable disease.
8) Patients with known brain metastases may be included as long as they have been clinically stable for one month or more, and are not receiving dexamethasone.
9) Have the ability to maintain a central intravenous access (e.g. PICC, Groshong, or Hickman line).
10) Signed informed consent prior to the start of any study specific procedures.
1) Patients that have received previous anticancer chemotherapy,
immunotherapy, radiotherapy or any other investigational therapy in the
4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry.
2) Patients that have received extensive prior radiotherapy to more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
3) Patients that have any concomitant condition that could compromise the objectives of this study and the patient's compliance.
4) Patients who are pregnant or lactating women.
5) Patients that have current malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer or have demonstrated no evidence of disease for 5 years or more.
6) Patients with clinically evident HIV, HBV, or HCV infection.
7) Patients that have a hematologic malignancy.
8) Patients that have a documented or known bleeding disorder.
9) Patients that have requirements for therapeutic anticoagulation that increases INR or aPTT above the normal range (low dose deep vein thrombosis [DVT] or line prophylaxis is allowed).
10) Patients with congestive heart failure.
11) Patients with > Grade 1 peripheral neuropathy (CTCAE version 3.0).
12) Patients having history of allergic reactions to platinum-based or liposomal agents.
13) Creatinine Clearance (calculated) </= 60 mL/min. ( using the Cockcroft Gault equation)
14) Patients receiving or initiating treatment with any other investigational agents.