Patients must not be on therapeutic anti-coagulation; prophylactic anti-coagulation (i.e., intraluminal heparin) of venous or arterial access devices is allowed
Acceptable coagulation status:
History of clinically significant coagulation or platelet disorder in the past 12 months.
Adequate blood coagulation function
Acceptable coagulation profile
Adequate coagulation function
PHASE II: History of bleeding diathesis; patients receiving anti-coagulation must be able safely interrupt treatment for tumor biopsy
Normal coagulation profile
Acceptable coagulation status, as specified below:
Adequate coagulation functioning within 28 days prior to study registration defined by either of the following criteria:
Patient not on anticoagulation has acceptable coagulation studies (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) below or within normal limits (+15%). Patients on anticoagulation must have coagulation values within the therapeutic range appropriate for the anti-coagulation indication.
Normal coagulation panel.
Have acceptable coagulation parameters defined as:
Subject who has a clinically significant coagulation disorder or disease, defined as a platelet count <100,000 per microliter, International Normalized Ratio >1.5, or a PTT more than 1.5 times outside the laboratory's normal reference range;
Subjects currently on anti-coagulation therapy are not eligible
Abnormal bleeding times or active anti-coagulation therapy
Adequate coagulation function
Requires continuous anti-coagulation or anti-platelet therapy that cannot be safely interrupted to allow for IT injection and/or history of coagulopathy.
Adequate coagulation profile.
Adequate coagulation profile:
Normal coagulation profile and no history of substantial non-iatrogenic bleeding diathesis
History of any inherited coagulation or platelet function, disorder or ITP, TTP, or HUS
Patients on therapeutic anti-coagulation are eligible if there is no bleeding and they are on a stable dose of anti-coagulation therapy (e.g., on coumadin with an international normalized ratio [INR] of 2 to 3) for at least 7 days before registration (prior to the start of therapy)
Patients must have normal coagulation profile and no history of substantial non-iatrogenic bleeding diathesis.
Have adequate coagulation functioning within 15 days prior to start of study treatment, defined by either of the following criteria:
Normal preoperative coagulation blood test (prothrombin time)
No ongoing anti-coagulation and/or anti-platelet therapies allowed
International normalized ratio (INR) < 2 if off of anti-coagulation; patients on anti-coagulation therapy with an INR > 2 may be enrolled at the discretion of the investigator if they have not had any episodes of severe hemorrhage
Hematologic (Coagulation Factors):
Patients receiving anti-coagulation therapy are eligible as long as anti-coagulation regimen has been stable for > 1 month
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; (patients on Coumadin or other blood thinning agents are eligible for this study)
Clinically significant coagulation disorder
All patients should have normal coagulation, with international normalized ratio (INR) < 1.3 and able to withhold anti-coagulation medications a minimum of 24 hours prior to radiosurgery (or until INR normalizes), on the day of treatment and 24 hours after radiosurgery has concluded; those patients getting WBRT may continue these medications
Patients who require the use of therapeutic anti-coagulation: except as required to maintain patency of preexisting permanent vascular catheter
No history of a coagulation disorder
Adequate coagulation: international normalised ratio (INR) ?1.5 for patients on anti-coagulation therapy
patients participation in other pharmaco therapeutic program with an experimental therapy that is known to effect the coagulation system;
Hepatic insufficiency not due to tumor resulting in clinical jaundice or bilirubin >1.5 x ULN and/or coagulation defects
Acceptable coagulation status
Clinically apparent jaundice and/or known coagulation defects
Hematologic (Coagulation Factors):
Have adequate coagulation function.
Acceptable coagulation profile
Abnormal coagulation parameters
Coagulation function tests not suggestive of severe liver dysfunction
Coagulation:
Hepatic insufficiency resulting in clinical jaundice and/or Coagulation defects
Abnormal and clinical significant coagulation parameters at the discretion of the Investigator, i.e.:
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for additional liver function tests and coagulation parameters are not required for entry into this protocol
Currently requiring any type of full-dose anti-coagulation treatment, systemic administration of antibiotics or chronic administration of anti-viral agents
Acceptable coagulation status
Known past or current coagulation defects.
Severely abnormal coagulation (INR>1.5)
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Adequate coagulation function
Eligible study subjects must exhibit acceptable liver, renal, and coagulation function as assessed by laboratory tests.
Subject has a clinically significant coagulation disorder or disease, defined as a platelet count < 100,000 per microliter or International Normalized Ratio > 1.5 within 4 weeks of surgery;
Adequate hematologic, organ, and coagulation within 2 weeks (14 days) prior to randomization.
Concurrent anti-coagulation therapy
Adequate coagulation functioning within 28 days prior to registration for protocol therapy defined by either of the following criteria:
Adequate coagulation
Patients on therapeutic dose anti-coagulation with warfarin, low molecular weight heparin (LMWH), or other anti-coagulants will be allowed to participate in the study; however, the anti-coagulants should be held pre- and post- research biopsy (when applicable) as per institutional standards; the risks of a temporary hold of anti-coagulation should be carefully considered and explained to the patient as part of the informed consent process; if it is not felt to be in the best interest of the patient to have anti-coagulation held, the patient may still enter the study, but should not undergo a research biopsy
Adequate coagulation parameters (within 21 days prior to registration)
International normalized ratio (INR) =< 1.5; patients are eligible if elevated INR is due to anti-coagulation medications and will need to provide documentation of stable coagulation parameters prior to study entry
Patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline
Patients with a history of deep vein thrombosis must be on anti-coagulation therapy prior to enrollment; patients requiring prophylactic anti-coagulation are eligible
Have adequate coagulation functioning within 15 days prior to start of study treatment, defined by either of the following criteria:
Coagulation
Patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline
Patients receiving anti-coagulation therapy are excluded
Normal coagulation panel.
Normal coagulation profile as evidenced by PT and aPTT ? 1.5 x ULN;
Normal Coagulation profile.
Congenital coagulation abnormalities
Normal platelet count and coagulation profile
Adequate coagulation function as defined by the following criteria:
Adequate coagulation status
Adequate coagulation parameters, defined as international normalization ratio (INR) ?
Evidence or history of any bleeding or coagulation disorder
History or suspicion of a congenital or acquired coagulation disorder.
Participants who need to take therapeutic anti-coagulation or anti-platelet therapy.
Acceptable coagulation status
Known past or current coagulation defects.
Patient on anti-coagulation therapy and are unable to stop therapy for the perioperative period
Acceptable coagulation status:
Coagulation status:
Coagulation Prothrombin time ? 1.5 X upper limit
Patients must not be receiving active anti-coagulation therapy at the time of study entry (or while on study).
Requires therapeutic anti-coagulation
No anti-coagulation therapy is allowed with the exception of low-dose aspirin
for intratumoral cohort, coagulation profile favorable to surgery
The patient is receiving full dose subcutaneous heparins or is under anti-coagulation treatment.
At the time of the second bronchoscopy (if clinically necessary), all patients will undergo routine laboratory tests including a CBC, chemistry 7 panel and coagulation profile
History of clinically significant coagulation or platelet disorder in the past 12 months
Thrombocytopenia (platelet count < 50 K) or coagulation disorder that would contraindicate intramuscular injection
Severely abnormal coagulation (INR>1.5)
History of bleeding/coagulation problems
Patients on anti-coagulation they must be able to safely stop treatment for purposes of tumor biopsy
Adequate coagulation defined as: