|Be willing and able to provide written informed consent/assent for the trial.|
|Be 18 years of age or older on day of signing informed consent.|
|Have a performance status of 0-3 on the ECOG Performance Scale.|
|Have a life expectancy of 6 months or more as determined by treating physician.|
|Have exhausted all other standard therapies; Have failed available therapy or are not a candidate for, or refuse available therapy (i.e. concerned with high adverse events rate in available therapy or outcome worse than disease); or failure of prior chemotherapy.|
|Histologically-documented solid cancer. All subjects must submit their primary tumor or metastatic pathology specimens and laboratory and imaging reports to Rampart Health where they will be centrally reviewed. Central Rampart Health pathologic review is not required for screening but rather for confirmation of diagnosis and histologic subtype of cancer. Local pathologic review is sufficient for eligibility determination.|
|Measurable disease as defined using iRECIST criteria and identified by radiographic imaging (Imaging should be current within the past three months of subject entering the study; if not repeat imaging must be done prior to enrollment.). In order to be eligible, the patient must have at least one metastatic bone and/or metastatic soft tissue site, lymph node site, and/or bone site with cancer mass measuring 1.0 cm or more in diameter based on soft tissue, lymph node, and/or bone lesions as defined by any of the following:|
- Any soft tissue lesion defined by imaging deemed by the physician to be consistent with distant metastatic disease. For patients undergoing PSMA PET (prostate cancer patients only), only PSMA avid lesions that have a CT or MRI correlate consistent with metastasis will be counted as a site of metastasis.
- Metastatic lymph node disease defined by imaging. Any lymph node ≥ 1.5 cm in shortest dimension will be noted as involved with disease.
- Bone metastases defined by bone imaging. If the patient has technetium bone scan and/or NaF PET performed, either study may be used for documenting metastases; both scans do not need to show the number of metastases required for study entry. For patients undergoing PSMA PET (prostate cancer patients only), only PSMA-avid lesions that are consistent with metastasis will be counted as a site of metastasis.
|The effects of the medications in this protocol on the developing human fetus are unknown. Any subject treated or enrolled on this protocol must agree to use adequate contraception prior to the first dose of study therapy, for the duration of the study participation, and for 120 days after the last dose of study therapy.|
|Their partners will also be encouraged to use proper method of contraception.|
|Acceptable initial laboratory values within 14 days of treatment initiation according to the following:|
- ANC ≥ 1500/µl
- Hemoglobin ≥ 9.0 g/dL(prior transfusion permitted)
- Platelet count ≥ 100,000/µl
- Creatinine ≤ 2.0 x the institutional upper limit of normal (ULN) OR creatinine clearance >30 ml/min
- Potassium ≥ 3.5 mmol/L (within institutional normal range)
- Bilirubin ≤ 1.5 x ULN (unless documented Gilbert’s disease)
- SGOT (AST) ≤ 2.5x ULN, or <5x ULN in patients with documented liver metastases
- SGPT (ALT) ≤ 2.5x ULN or <5x ULN in patients with documented liver metastases
- Albumin >2.5 mg/dL
- Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
- Deviation from these values is allowed at the discretion of the treating investigator.
|NOTE: Women of child-bearing potential will be tested for pregnancy (which must be negative) before treatment is given. Acceptable range is < 5 mIU/mL|
|No active major medical or psychological problems that could be complicated by study participation.|