Dose Escalation Study of Nelfinavir Plus MLN9708 in Patients With Advanced Solid Tumors or Lymphoma

Inclusion Criteria

• •Advanced or metastatic, histologically/cytologically confirmed malignant solid tumor or any lymphoma, not expected to clinically benefit from standard therapy.
• •Life expectancy greater than 3 months.
• •Previous chemotherapy and/or radiotherapy must have been completed at least four weeks before enrollment(six weeks for prior treatment with mitomycin or nitrosoureas) and patients should have recovered from all toxicities of that therapy before treatment under this protocol.
• •All patients must have recovered from any surgical procedure.
• •Serum creatinine must be within the institutional limits of normal and an estimated creatinine clearance of ≥ 60 mL/min.
• •Calculated by: Weight (in kg) X (140 - age) / (72 X Serum Creatinine)
• •In females, multiply by 0.85. Alternatively, creatinine clearance may be measured from a 24 hour urine collection.
• •Total bilirubin \<2 x ULN. SGOT/AST and ALT must be less than or equal to 2.5 times the upper limit of institutional normal.
• •Hb \> 9.0 g/dL and absolute neutrophil count ≥ 1,500/mm3, and platelet count ≥ 100,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
• •Patients must be 18 years of age or older.
• •Patients must have a Karnofsky Performance Status of \>70%
• •Female patients who:
• •* Are postmenopausal for at least 1 year before the screening visit, OR
• •* Are surgically sterile, OR
• •* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND
• •* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
• •* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, sympto-thermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)
• •Male patients who:
• •* Even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
• •* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
• •* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
• •* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, sympto-thermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)
• •Brain metastases must be treated and stable for at least 3 months before the start of the treatment
• •Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.