Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
Visceral crisis or lymphangitic spread\r\n* NOTE: Visceral crisis is not the mere presence of visceral metastases, but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease
Visceral crisis or impending visceral crisis at time of screening
Subjects with bulky visceral disease defined as > cm
Symptomatic or rapid visceral progression
Evidence of visceral metastasis to the liver.
have impending visceral crisis that requires chemotherapy;
Patients who have any liver metastases or visceral metastasis of ? cm, plus evidence of progression meeting irRC . within month before the first OBP- administration.
Patients who have noncanonical DNA repair defects and extensive visceral disease or symptomatic bone disease requiring urgent tumor response
Identified as having visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis; visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease
Requires urgent treatment with cytotoxic chemotherapy or other therapy is indicated (e.g., symptomatic visceral metastases)
Patients with parahepatic extension of disease with direct non-liver visceral involvement
No visceral crisis: Visceral crisis is moderate-to severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease
Development of visceral crisis since pre-registration.\r\n* NOTE: Visceral crisis is moderate-to-severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease.
Patients with definite liver metastasis > cm or signs of visceral crisis or impending visceral crisis at the clinical discretion of the treating physician
Subjects with retroperitoneal and visceral sarcoma
Visceral crisis or rapidly progressive disease for which chemotherapy would be indicated
Symptomatic visceral KS (except for non-ulcerating disease restricted to the oral cavity)
Symptomatic liver or visceral organ metastasis
Evidence of liver metastases or visceral disease
Visceral metastases (e.g. lung, liver, brain, kidney, spleen)
Patients must be classified as having intermediate or poor-risk germ cell tumor, as follows:\r\n* Intermediate-risk (modified*)\r\n** Testis or retroperitoneal primary non-seminomatous germ cell tumors (NSGCT) with lymph node and/or lung metastasis but without non-pulmonary visceral metastasis AND any of the following pretreatment serum tumor marker (STM) values:\r\n*** Lactate dehydrogenase (LDH) from to < x upper limit of normal (ULN) (*this differs from the original International Germ Cell Cancer Collaborative Group [IGCCCG] criteria which includes patients with LDH from . to x ULN)\r\n*** Serum human chorionic gonadotrophin (HCG) from , to < , MIU/mL\r\n*** Serum alpha-fetoprotein (AFP) from , to < , ng/mL\r\n** Seminoma histology regardless the primary site or serum tumor markers with any non-pulmonary visceral metastasis (liver, bone, brain, etc)\r\n* Poor-risk (any of the following):\r\n** Testis or retroperitoneal NSGCT primary with non-pulmonary visceral metastasis (liver, bone, brain, etc) regardless the STM values\r\n** Mediastinal NSGCT primary site of disease regardless the presence/absence of visceral metastasis or STM values\r\n** Testis or retroperitoneal NSGCT primary without non-pulmonary visceral metastasis but with poor-risk STM values:\r\n*** LDH >= x ULN\r\n*** HCG >= , MIU/mL\r\n*** AFP >= , ng/mL
Visceral metastasis (excluding liver metastases) and/or lymphadenopathy
Presence of skeletal, and/or soft-tissue/visceral/nodal metastasis
have visceral crisis
No current evidence of visceral crisis or lymphangitic spread
No visceral crisis, lymphangitic spread or known brain metastases: visceral crisis is not the mere presence of visceral metastases, but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease
Visceral (ie, liver or lung) metastases as only sites of metastases
Presence of unstable systemic disease (e.g., visceral crisis or rapid progression) in the judgment of the investigator
Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
Pending visceral crisis, in the opinion of the treating investigator
Visceral (eg, lung, liver) metastatic disease. Adenopathy is allowed;
Has rapid progression of visceral disease and, thus is a candidate for docetaxel; this determination will be at the discretion of the treating physician
Histologic diagnosis of melanoma with metastatic disease to a visceral organ (lung, liver, brain, adrenal, nodal station outside the regional lymph drainage of the primary, vertebral bodies)
A visceral metastasis greater than cm
A visceral metastasis that due to its location cannot be safely treated with SABR
Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease
History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations
History of visceral metastasis, or visceral metastases
History of visceral metastasis, or visceral metastases
COHORT B: Visceral metastatic disease
Patients experiencing a visceral crisis including severe organ dysfunction as assessed by > grade (Gr) symptomatic toxicities, laboratory studies, and/or rapid progression of disease originating from visceral metastasis
Symptomatic liver or visceral organ metastasis
Patients with rapidly progressive or extensive symptomatic visceral metastatic disease
Pending visceral crisis, in the opinion of the treating investigator
Patients who require or may be expected to require urgent treatment with docetaxel during the study (e.g., patients with visceral metastases).
Presence of >= metastatic site (nodal, visceral) that is amenable to core biopsy
Participants must have biopsy-proven KS involving skin with or without visceral involvement
Patients with visceral disease are ineligible
Patients in whom urgent treatment with docetaxel is indicated, per clinician discretion; this includes, but is not limited to patients with symptomatic visceral metastatic disease
Patients with paraspinal extension of disease with visceral involvement
Presence or history of visceral melanoma metastasis
Eligible for taxane monotherapy, as per local investigator assessment (e.g., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control which may require combination chemotherapy)
Cohort A: Patients must have at least one measurable visceral lesion (per RECIST .); a visceral lesion is any solid organ except for skin, lymph node, and musculoskeletal tissue; at least one of these visceral lesions must be measurable per RECIST .
Cohort B: Patients must not have any visceral lesions
AIM : Patients with either cutaneous, visceral or brain melanoma metastases
Visceral (e.g. lung, liver) metastases