Histologically-confirmed angiosarcoma that is not amenable to curative intent surgery (e.g., metastatic or bulky disease and disease for which surgical resection would carry an unacceptable risk to the patient). Pathology report will be reviewed by sponsor prior to randomization.
For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality, neoadjuvant chemoradiation followed by curative intent surgical resection
Disease that is currently not amenable to surgery, radiation, or combined modality therapy with curative intent
Patient must have no prior history of RCC that was resected with curative intent within the past 5 years
Surgical resection with curative intent within 8 weeks prior to registration
Eligible for surgery with curative intent
Have received only one prior radiation treatment course; prior radiation course must have been with curative intent
Histologically or cytologically proven diagnosis of advanced stage angiosarcoma that is not amenable to treatment with curative intent; specify site of origin as cutaneous vs. non-cutaneous
Other prior malignancy active within the previous 2 years except for local or organ-confined early stage cancer that has been definitively treated with curative intent or does not require treatment, does not require ongoing treatment, has no evidence of active disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the endpoints of the study.
Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
Received at least 2 cycles of one prior regimen administered with curative intent and one of the following:
Localized prostate cancer that has been treated surgically with curative intent and presumed cured
Patient has histologically/cytologically confirmed, non-keratinizing/undifferentiated, EBV-related nasopharyngeal carcinoma, not amenable to curative intent therapy; EBV testing may be completed per institutional standards
Subjects have no known curative treatment.
Are eligible for a curative treatment option.
Other prior malignancy active within the previous 3 years except for local or organ confined early stage cancer that has been definitively treated with curative intent, does not require ongoing treatment, has no evidence of residual disease and has a negligible risk of recurrence and is therefore unlikely to interfere with the primary and secondary endpoints of the study, including response rate and safety
Primary disease site must be able to be treated with curative intent
Another active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized non-melanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment; patients with >= 25% of the bone marrow radiated for other diseases are not eligible
The subject is a candidate for surgery or loco-regional treatment with curative intent.
Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
Disease that is currently not amenable to surgical resection with curative intent as determined by the treating investigator
Possibility of a curative local treatment (surgery and/or radiotherapy)
Patients who have a standard curative option for their lymphoid malignancy at current state of disease are excluded; for eligibility on this trial, allogeneic stem cell transplantation is not considered a standard curative option
Malignancy treated with curative intent and with no known active disease > 5 years prior to the start of CMP-001 dosing on W1D1 and of low potential risk for recurrence.
Recurrent/metastatic disease, fulfilling at least one of the criteria defined below:\r\n* Incurable disease as assessed by surgical or radiation oncology\r\n* Metastatic (M1) disease\r\n* Persistent or progressive disease following curative-intent radiation, and not a candidate for surgical salvage due to incurability or morbidity; patients who decline radical surgery are eligible
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; requires discussion with TA MD.
Has not achieved disease-free status after completion of CCRT administered with curative intent.
Documented disease progression occurring within 12 months from the last treatment with curative intent
Has newly diagnosed disease (no prior chemotherapy, radiation or surgery with curative intent for this sarcoma diagnosis – prior surgery for diagnostic purposes are allowable)
Plans to undergo neo-adjuvant radiation and surgery with curative intent
Have evidence of persistent, recurrent, or progressive disease for which there is no known or established treatment available with curative intent, after failing at least one course of community standard systemic treatment with chemotherapy (and endocrine therapy if appropriate)
Participants must have disease that has progressed on prior treatment and is not amenable to surgical resection or other approved therapeutic options with curative intent. Participants must not be eligible for further therapy that is likely to provide a survival benefit
Deemed ineligible for curative intent therapy with surgical resection or liver transplantation
Availability of curative treatment option for the patient’s cancer, whether surgery, chemotherapy, radiation, or combination thereof, unless the patient has documented refusal of curative treatment
Histologically documented differentiated thyroid cancer with or without metastases, not amenable to curative treatment; or the patient has documented refusal of curative treatment
Have evidence of persistent, recurrent, or progressive disease for which there is no known or established treatment available with curative intent, after failing at least one course of community standard systemic treatment with chemotherapy (and endocrine therapy if appropriate)
Patients must not be eligible for therapy with curative intent (i.e. surgery, radiation, etc)
For patients undergoing curative intent resection the following criteria are required:
If a curative treatment option in the form of chemoradiation exists in a patient with unresectable disease, this has to be attempted first and must have failed, unless the patient has documented refusal of curative treatment
Availability of curative treatment option for the patient’s cancer, whether surgery, chemotherapy, radiation, or combination thereof, unless the patient has documented refusal of curative treatment
ALL patients who have relapsed or have residual disease following treatment with curative intent; ALL patients must have ROR1 expressed on > 90% of the leukemia blasts to be eligible
Be eligible for curative-intent concurrent chemoradiation therapy
Patients will not have any other curative therapeutic option, such as radiation or surgery
In the absence of a being treated on a clinical trial, the patient would be recommended to receive neoadjuvant chemoradiation followed by curative intent surgery
Patients with prior malignancies are allowed, provided they have been treated with curative intent and have no evidence of active disease
Patients will not have any other curative therapeutic option, such as radiation or surgery
Surgery intent within 4 weeks
Fit to receive chemotherapy and radiotherapy with curative intent.
Subjects must not be candidates for hepatic surgery or locoregional therapy of liver tumors with curative intent.
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Disease is surgically resectable with curative intent
Has current NSCLC disease that can be treated with curative intent with surgical resection, localized radiotherapy, or chemoradiation
Brain metastases unless treated with curative intent (gamma knife or surgical resection) and without evidence of progression for ? 2 months.
Be appropriate candidates for resection and curative intent therapy in general
Patients who have had prior chemotherapy, radiotherapy, or surgery with curative intent for HNSCC
Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been disease free for the time period considered appropriate to not interfere with the outcome of this study
Prior cytotoxic chemotherapy for another condition treated with curative intent is allowed provided at least 18 months has elapsed between last treatment and enrollment on protocol
Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer; for most diseases this time frame is 5 years
At least 6 months since prior treatment with curative intent and recurrence
Histologically confirmed hepatocellular carcinoma not amenable for management with curative intent by surgery or local therapeutic measure;
No other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized non-melanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment
Prior systemic chemotherapy unless it was part of definitive-intent (curative intent) treatment more than 6 months before study entry
Eligible for curative treatment (ablation or transplantation)
Disease surgically resectable with curative intent
Participant completed all prior radiotherapy with curative intent ? 3 weeks prior to randomization
Prior curative-intent surgery at least 3 months prior to the nodal recurrence.
Surgically eligible for tumor resection with curative intent
Has a history of prior cancers not included in this study that were either not treated with curative intent or have been active within the past 5 years
Active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized nonmelanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment
Patients who have a standard curative option for their lymphoid malignancy at current state of disease are excluded; for eligibility on this trial, allogeneic stem cell transplantation is not to be considered a standard curative option
Recurrent/metastatic disease, fulfilling at least one of the criteria defined below:\r\n* Incurable disease as assessed by surgical or radiation oncology\r\n* Metastatic (M1) disease\r\n* Persistent or progressive disease following curative-intent radiation, and not a candidate for surgical salvage due to incurability or morbidity; patients who decline radical surgery are eligible
Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening.
Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.
Patients who are eligible for curative treatment (ablation or resection or transplantation)
Recurrent or persistent measurable disease that has progressed (defined as radiological and/or clinical progression; an increase in cancer antigen [CA]-125 alone is not sufficient) on or after last therapy (i.e., chemotherapy, hormonal therapy, surgery) and is not amenable to potentially curative intent surgery, as determined by the patient's treating physician.
Patients who have a standard curative option for their lymphoid malignancy at current state of disease are excluded; for eligibility on this trial, allogeneic stem cell transplantation is not to be considered a standard curative option
Recurrent NSCLC, who relapse less than one year after completing curative intent therapy
Completed all acceptable therapies with curative intent that are the current standard of care for their respective diseases. If no conventional therapy available, patient may participate after review by sponsor.
The patient has progressed within 6 months after completion of curative intent (definitive) treatment for localized/locoregionally advanced disease.
For subjects receiving adjuvant therapy only, subjects with node positive disease must have undergone treatment of axillary LN with curative intent, or subjects must be scheduled for further treatment of regional lymph nodes with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization
Patients must be eligible for curative intent surgical resection
Patient must continue to be eligible for curative intent surgical resection
Prior radiotherapy with curative intent
Prior chemo-radiotherapy with curative intent
Newly diagnosed inoperable cervical cancer treated with chemoradiation therapy with curative intent and life expectancy of at least 12 months as assessed by the investigator o No CNS/spinal metastases
Patient is receiving concurrent radiation therapy to treat primary disease with curative intent. (Note that palliative radiotherapy is allowed as long as there is no evidence of progressive disease.)
Inability to start study treatment within 12 weeks following the completion of curative intent therapy for rectal adenocarcinoma
Disease that is currently not amenable to surgery, radiation, or combined modality therapy with curative intent
Active suicidal ideation with plan and intent
Treated with intent to cure
Not treated with intent to cure
Completed curative intent therapy, without additional standard of care curative intent therapy feasible within 20 weeks prior to study enrollment
After prior curative intent treatment for HNC have estimated risk of recurrence >= 40-50% and fall into one of the below categories (A, OR B, OR C, OR D, OR E, OR F); while exact estimation of the risk of recurrence can be difficult the following categories will be included reflecting patients at substantial risk for tumor recurrence or already with early evidence of recurrence:\r\n* A: Any of the below HNC patients are eligible for treatment on this protocol AFTER completion of curative intent therapy:\r\n** HPV(-) HNC: N2C, N3, bulky N2B disease (>= 5 cm LN/tumor conglomerate)\r\n** HPV(+) HNC: N2C, N3, AND >= 10 pack years of tobacco use\r\n** HPV(+) HNC with multilevel nodal involvement, AND bulky N2B disease (>= 5 cm LN/tumor conglomerate), AND >= 10 pack years of tobacco use\r\n** EBV(+) nasopharyngeal carcinoma (NPC) may be eligible if other criteria under A, or alternative criteria B, or C, or D, or E are met\r\n** HNC with supraclavicular or mediastinal nodal involvement (either HPV+/- or EBV+/-) at the time of curative intent treatment and were treated as part of curative intent therapy (e.g. inclusion in the radiation field)\r\n** Residual mass in area of prior tumor that on biopsy does not show residual tumor, is equivocal/not highly-suspicious on imaging (e.g. positron emission tomography/ computed tomography/magnetic resonance imaging [PET/CT/MRI]), but remains of concern, requires close follow-up AND is not resected/amenable to resection OR immediate palliative treatment\r\n** Non-responders to induction chemotherapy (progressive disease [PD] on induction, or lack of tumor shrinkage (< 15% per Response Evaluation Criteria in Solid Tumors [RECIST])\r\n** Interrupted treatment course or lower than intended radiation dose – i.e. interruption of radiation by >= 3 weeks (cumulative), or delivery of =< 50 Gy as part of a radiation based treatment (that was NOT a de-escalation approach)\r\n* B: Patient treated with salvage treatment (i.e. salvage surgery or re-irradiation) for residual or recurrent tumor after prior radiation based therapy (either HPV+ or HPV- or EBV+) AND not a candidate for additional curative intent therapy (for various reasons including poor performance status, comorbidities, refusal of patient, prior radiation or re-irradiation, etc); positive margins or residual tumor may still be acceptable); patients should also not be appropriate for systemic palliative therapy (e.g. in the case of overt disease)\r\n* C: Mx or indeterminate distant lesions that are not appropriate for either local radiation/stereotactic body radiation therapy (SBRT) treatment and also not appropriate for initiation of palliative system therapy (e.g. in the setting of overt metastatic disease); such lesions should be negative/equivocal by PET imaging and if amenable negative by biopsy, but remain of concern and require close follow-up\r\n* D: Oligometastatic disease treated with SBRT or other curative-intent therapy (e.g. surgery or radiofrequency ablation (RFA), etc) for oligometastatic disease\r\n* E: Microscopic or very low volume residual tumor after surgery or radiation based treatment (including salvage treatment or SBRT for oligometastatic disease), AND not a candidate for either additional curative intent therapy (for various reasons including feasibility, poor performance status, comorbidities, refusal of patient, prior radiation or re-irradiation, etc) AND also not a candidate for systemic palliative therapy (for various reasons including microscopic/non-[RECIST] measurable low volume disease); very low volume disease is defined as non-RECIST measurable)\r\n* F: Patients with multiple recurrences or multiple primaries: specifically patients who had malignant or pre-malignant tumors/changes (with severe dysplasia present), who have undergone surgery >= 2 times, and currently do not have an indication for additional (adjuvant) treatment such as radiation, or surgery, or other treatment; this may include multiple recurrences/incidences of early stage tumors or premalignant lesions, however at least one lesion needs to show squamous cell carcinoma on pathology\r\n* There may be additional scenarios for patients that are considered very high risk for disease recurrence and not appropriate for either curative or standard of care palliative therapy; such patients can be considered for enrollment after discussion and approval by the principal investigator (PI) and/or co-PI
Not amenable to treatment with curative intent
Patients scheduled to undergo surgical resection for curative intent during study participation
Patients to be treated with RT for curative intent
Patient undergoing any resection requiring an anastomosis to the esophagus for curative intent; including but not limited to esophagectomy or total gastrectomy
Completed cancer treatment with curative intent
Patient has histologically proven colorectal cancer or polyp(s) that is planned to be treated by surgical resection performed with curative intent
Other prior malignancy active within the previous 2 years except for local or organ confined early stage cancer that has been definitively treated with curative intent or does not require treatment, does not require ongoing treatment, has no evidence of active disease and has a negligible risk of recurrence and is therefore unlikely to interfere with the endpoints of the study
Patients who are receiving a course of radiation therapy for curative or adjuvant intent
Patients who have been diagnosed with locally advanced unresectable NSCLC undergoing definite chemo-radiation with curative intent
Macroscopic resection of the tumor via TORS must be planned with curative intent
Eligible for at least 2 cycles of standard of care AML chemotherapy that will result in moderate to severe myelosuppression and have curative intent
Patients may be enrolled between 3 months and 5 years AFTER completion of curative-intent therapy (including surgery, radiotherapy, and/or chemotherapy)
Planned curative intent chemotherapy, delivered either concurrently or sequentially in combination with radiotherapy
Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent
Must be in acceptable health to undergo radiation therapy and curative intent surgery as assessed by UNC surgeons and radiation oncologist
Must receive their neoadjuvant radiation therapy and curative intent surgery at UNC Hospitals – Chapel Hill location
Medical conditions precluding radiation therapy or curative intent surgery
Planned standard of care surgery with curative intent for squamous cell carcinoma
Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
Planned standard of care surgery with curative intent for squamous cell carcinoma
History of malignancy that is in complete remission after treatment with curative intent is allowed.
Patients with known, active (i.e. not adequately treated with curative intent) malignancies other than melanoma
Patients who underwent, currently undergoing or planned to start radiation treatment with curative, adjuvant or palliative intent, who have not yet had their first post-treatment visit
Patients must have completed all therapy for curative intent at least six months prior to chart audit
Criteria 1, Participant is a candidate for hepatic surgery or local regional therapy of liver metastases with curative intent
Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
For phase Ib only: Pretreated patients, and not amenable to further therapy with curative intent. This part is open to pretreated patients regardless of the number of previous treatment lines. For phase II only: Patients who received a maximum of two prior systemic regimens for recurrent and/or metastatic disease and not amenable to further therapy with curative intent.
No prior curative attempts for this cancer, (i.e., surgery, radiation and/or other)