Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration; patients must have recovered (=< grade 1) from any side effects of prior therapy; patients must not have received any radiation therapy within 14 days prior to sub-study registration
>= 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy
Patients must have had no prior systemic therapy
GCTs: no limit of prior therapy
The last dose of prior systemic therapy (e.g. chemotherapy, targeted therapy etc) or radiation therapy (with the exception of palliative radiotherapy) was received less than 14 days prior to the first day of treatment
Have progressed on prior systemic therapy
Phase 1b only: Advanced solid malignancy with an emphasis on colorectal, head and neck, breast, pancreatic and ovarian cancers who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available.
Relapsed or are refractory to at least 1 prior systemic cytotoxic therapy. -Subjects must have received conventional therapy as a prior therapy.
Prior systemic therapy for incurable disease
Prior systemic therapy:\r\n* Participants must have discontinued systemic therapy at least 14 days prior to initiating protocol therapy.\r\n* There is no limit to the number of prior lines of systemic therapy. Participants who have not received any systemic therapy for metastatic disease are also eligible.\r\n* Participants may initiate or continue bisphosphonate therapy on study
Patients must have at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) for their sarcoma if standard treatment is appropriate. Treatment naive patients may be enrolled if they have refused standard systemic treatment. Prior adjuvant therapy will not count provided it was completed more than 6 months previously.
A) Patients enrolled into the dedifferentiated liposarcoma cohort do not require prior systemic therapy (may be naive to systemic therapy); B) leiomyosarcoma patients must have had at least 1 prior systemic therapy (does not include adjuvant/neoadjuvant therapy in a curative setting). There are no limits on prior number of therapies for either cohort
Patients must have been treated with at least one prior systemic regimen for sarcoma; adjuvant systemic therapy qualifies as prior therapy for the purposes of this study; there is no upper limit on previous lines of therapy received; a prior line of systemic therapy may include prior investigational agents received as part of other clinical studies
Must have received at least one prior systemic therapy
Prior therapy with any systemic therapy (chemotherapy or biologic therapy) within twenty-eight days prior to study entry
Prior systemic chemotherapy or therapy with one of the investigational agents within 1 month prior to enrollment
Prior systemic therapy
Prior malignancies requiring systemic therapy within the last 3 years (as prior therapy can increase toxicity of current chemo regimen, those patients should be excluded).
Patients may have received prior systemic and/or radiation therapy. All adverse events associated with prior systemic therapy or radiation therapy must have resolved to =< grade 1 prior to start of study
No prior systemic therapy for lymphoma
Subjects must have at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) for their sarcoma; an exception to this criterion will be made for patients with sarcoma histological subtypes for which there is no known standard systemic therapy (e.g., chondrosarcoma); any patient that refuses standard chemotherapy for the treatment of their disease is also considered eligible; prior adjuvant therapy will not count provided it was completed more than 6 months previously
No prior therapy for this disease
Have received any number of prior systemic therapies for metastatic disease; prior radiation therapy (any number) and interferon use (any formulation and/or duration) in the adjuvant or metastatic disease settings is permitted; vaccine therapy will be counted as systemic therapy
Systemic therapy is allowed but SBRT cannot begin until >= 7 days after the last cycle of systemic therapy, and systemic therapy cannot be initiated or re-initiated until >= 7 days after SBRT; there will be no limit on prior lines of systemic therapy
Prior systemic chemotherapy, immunotherapy, or biological therapy, radiation therapy and/or surgery are allowed; prior use of systemic methotrexate > 1 month prior to study entry is allowed. Intrathecal methotrexate is allowed prior to and during treatment per investigator discretion.
Prior systemic therapy or radiation therapy for treatment of the current lung cancer
Must have received at least one prior systemic therapy, and must have relapsed or progressed after, or failed to respond to any/all available effective therapy or therapies.
Subjects must have at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) for their sarcoma; an exception to this criterion will be made for patients with sarcoma histological subtypes for which there is no known standard systemic therapy (e.g., chondrosarcoma); prior adjuvant therapy will not count provided it was completed more than 6 months previously
At least 14 days must have elapsed since any prior systemic therapy prior to apheresis and prior to the initiation of chemotherapy (including systemic corticosteroids at any dose); systemic anti-malignancy therapy including systemic corticosteroid therapy of any dose is not allowed within 14 days prior to the required leukapheresis\r\n* NOTE: 30 days must elapse from the time of administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the principal investigator (PI) can stimulate immune activity and infusion of CAR T cells
At least one prior systemic treatment (including neoadjuvant therapy) for their tumor of the small intestine, with intolerance to prior therapy, failure of the most recent therapy (of any line) or recurrent disease
Metastatic renal cell cancer patients (any histologic subtype) with measurable and/or evaluable disease who have completed at least one line of prior systemic therapy are potentially eligible for this trial; any number of prior systemic therapies are allowed, including prior nivolumab
No prior systemic chemotherapy for transitional cell carcinoma of the bladder (prior intravesical therapy is allowed); any other prior chemotherapy must have been completed > 5 years prior to initiation of therapy
Patients may have received prior systemic and/or radiation therapy; all adverse events associated with prior systemic therapy or radiation therapy must have resolved to =< grade 1 prior to start of study
At least 14 days must have elapsed since any prior systemic therapy prior to apheresis and prior to the initiation of chemotherapy (including systemic corticosteroids at any dose); systemic anti-malignancy therapy including systemic corticosteroid therapy of any dose are not allowed within 14 days prior to the required leukapheresis; NOTE: 60 days must elapse from the time of administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the principal investigator (PI) can stimulate immune activity and infusion of CAR T cells
May have received at least 1 prior therapy for recurrent or metastatic disease, up to 2 prior systemic therapies.
Completion of prior systemic therapy at least 14 days prior to enrollment
No more than 3 prior progressions
Prior therapy
Planned systemic therapy after orbital radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of adjuvant systemic therapy
Prior systemic therapy
Prior therapy for melanoma that may include surgery, radiation therapy, immunotherapy including interleukins and interferon, and/or ?2 different regiments of systemic chemotherapy, targeted therapy, or other experimental systemic therapies. Prior treatment with immune checkpoint inhibitors is not allowed.
Systemic immunoglobulin therapy within the last 30 days
Candidate for further therapy and able to wait 7 days prior to start of next systemic therapy
Patients must be refractory or intolerant to at least 1 prior standard systemic therapy, if a candidate for systemic therapy
Patients who have received topical therapy, systemic chemotherapy, or biological therapy within 4 weeks prior to registration are NOT eligible for participation
Patients may not have received prior systemic chemotherapy for metastatic/advanced urothelial carcinoma; note: prior neoadjuvant/adjuvant therapy is permitted if completed >= 12 months prior to registration for protocol therapy; prior intravesical therapy is permitted
Prior AQ4N therapy.
Failed at least 1 prior systemic therapy
History of prior treatment with at least one line of systemic anticancer therapy, when an approved systemic therapy is available, and no curative option is available for continued treatment
Prior systemic treatment
Patients must have never received any prior systemic therapy for their disease.
Patients who have had systemic therapy or radiotherapy within 3 weeks prior to the first dose of study therapy
Patients must have received at least one prior systemic therapy for lymphoma; a washout period of at least 3 weeks is required from the most recent prior therapy
Has had prior systemic therapy (exception: GnRH agonist or antagonist) or radiation therapy for prostate cancer within 2 weeks prior to study day 1; there must be at least a 2 week washout period from last dose of any prior systemic or radiation therapy for prostate cancer prior to day 1 of study treatment (including nonsteroidal antiandrogens); screening may commence during this washout window
Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to Step 2 re-registration; patients must have recovered (=< grade 1) from any side effects of prior therapy
Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to re-registration; patients must have recovered (=< grade 1) from any side effects of prior therapy
Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to step 2 re-registration; patients must have recovered (< grade 1) from any side effects of prior therapy
Patients must not have received any prior systemic therapy (chemotherapy or other biologic therapy) for their unresectable malignant pleural mesothelioma; prior systemic chemotherapy or biologic therapy is allowed as neoadjuvant or adjuvant treatment, disease has now recurred, and all systemic treatment was completed > 6 months prior registration; prior therapy must not have included cediranib
Prior resection permitted, no prior systemic, ablative or infusion therapy permitted
Patient has not received prior anti-angiogenic therapy, systemic targeted agents or systemic chemotherapy\r\n* Prior surgical resection, chemoembolization or other local therapy prior to transplant is permitted
Prior Therapy Criteria:
Prior systemic therapy requirements.
Prior systemic chemotherapy (prior intravesical therapy is allowed)
Patients must not have received any prior systemic therapy (chemotherapy or other biologic therapy) for lung cancer
Subject has received no prior systemic therapy
Must not have received any prior systemic therapy for their mRCC.
Prior systemic therapy or radiation therapy for treatment of the current lung cancer
Prior malignancy requiring systemic therapy or radiation therapy within 1 year of randomization
Prior treatment with any type of systemic therapy for advanced disease.
Prior systemic therapy within 14 days of study enrollment; patients must be adequately recovered from prior systemic therapy side effects as deemed by the treating investigator
Prior systemic chemotherapy (prior intravesical therapy is allowed)
Relapsed or are refractory following at least 2 prior systemic therapeutic attempts (1 prior systemic attempt for PTCL). For CTCL, extracorporal photochemotherapy (ECP) will be considered a systemic therapy. Local radiation and topical agents are not systemic therapies.
NSCLC that has progressed during or following 1 - 5 prior systemic therapies for unresectable locally advanced or metastatic disease (at least one docetaxel, gemcitabine, or platinum analogue based therapy), or are intolerant of or refused standard cancer therapy. For squamous cell carcinoma, or adenocarcinoma without known activating mutation: the prior systemic therapy is at least one platinum analogue. For adenocarcinoma with known activating driver mutation: the prior systemic therapy is at least TKI directed
No systemic therapy for RRP for four weeks prior to treatment
Prior systemic therapy for WM
No prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed > 6 months prior if given as part of multimodal treatment for locally advanced disease)
Prior RRx-001 therapy
No more than 2 prior courses of systemic therapy for metastatic melanoma
Prior treatment with sunitinib or any other systemic therapy in the metastatic setting (prior neo/adjuvant therapy will be allowed if completed > 6 months prior to registration and therapy not discontinued for toxicity)
Disease Status and Prior Therapy:
Prior Therapy
Patients may have received prior systemic therapy (chemotherapy, immunotherapy, biologic therapy, or combination regimens); all adverse events associated with prior treatment must have resolved to =< grade 1 prior to registration
Subjects who have failed at least one prior course of systemic therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy
Prior systemic chemotherapy (prior intravesical therapy is allowed)
Participants with pcALCL who have received prior radiation therapy or at least 1 prior systemic therapy; participants with MF who have received at least 1 prior systemic therapy
Patients may have received prior systemic chemotherapy; such therapy must have been completed at least 5 years prior to study entry and the patient has no evidence of disease subsequent to such therapy
Prior systemic therapy within 28 days of study enrollment
No prior systemic therapy for lymphoma including chemotherapy or immunotherapy. Patients may have received involved-field radiation therapy which has been discontinued at least 4 weeks prior to treatment in this study.
No prior systemic therapy; prior adjuvant therapy with interferon does not count
Received at least one regimen of prior systemic therapy and then experienced documented radiographic progression or was not able to tolerate prior systemic therapy.
Patients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC. Patients who have received prior therapy must have had disease progression within 6 months of the last dose of previous systemic therapy
Has received prior systemic therapy for the treatment of SCLC
Prior therapy
Previous use of systemic therapy for bone metastasis is allowable as long as the systemic therapy use fits within the treatment plan as described in Proposed Treatment/Study Plan; (if the patient received less than 3 - 9 months of systemic therapy previously, the use of additional systemic therapy may be necessary to fit within the treatment plan)
Patients with immanent risk of fracture(s) may receive local therapy prior to systemic therapy; otherwise systemic therapy should be given first
Prior therapies:\r\n* Patients may have received one line of non-gemcitabine containing chemotherapy regimen\r\n* Patients may have received prior adjuvant chemotherapy and/or radiation therapy greater than 6 months prior to the time of study enrollment\r\n* Patients may have received “maintenance” therapy, e.g. lower dose capecitabine after completion of adjuvant therapy; this will not be considered as therapy for metastatic disease AND will patients may have been on maintenance therapy within the 6 months prior to initiating gemcitabine plus nab-paclitaxel, i.e. right up until the initiation of first-line therapy for metastatic disease\r\n* Timing of prior therapies:\r\n** At least 14 days must have passed since all prior anti-cancer therapy, including chemotherapy, biological therapy, or radiation therapy, and any prior investigational agent\r\n** However, at least 21 days must have passed since any prior antibody-based therapies (such as, but not limited to cetuximab or bevacizumab)\r\n** All patients must have completely recovered from all transient side effects related to prior therapies\r\n*** However, any side effects that are expected to be more durable or even permanent (e.g., neurotoxicity or ototoxicity) must have resolved to at least grade 1
Prior Therapy
Prior therapy:
For Phase II: Any prior systemic therapy for locally advanced or metastatic melanoma; prior local therapy such as radiation or intratumoral injection is allowed; previous systemic treatment for any stage III disease that was subsequently rendered NED (no evidence of disease) by surgery is allowed
Prior systemic chemotherapy (prior intravesical therapy is allowed)
Prior therapy with an hypoxic cytotoxin
Treatment naïve or has received only one systemic therapy apart from adjuvant therapy.
Prior therapy defined as 1 prior systemic therapy for advanced disease
History of prior treatment with at least one line of systemic anticancer therapy, when an approved systemic therapy is available, and no curative option is available for continued treatment.
For participants with recurrent SCCHN, prior systemic therapy is allowed if it was given as part of induction or definitive therapy. If participants have received prior combined chemo-radiation therapy, they must be off therapy for at least 3 months
Failure of at least one prior therapy
At least one prior therapy;
Part D - Diagnosed with cholangiocarcinoma and have not received more than 1 prior systemic therapy
Prior therapy for this cancer
Prior treatment with Scrambler therapy
Hepatic locoregional therapy following prior systemic therapy or within 28 days prior to randomization.
Any prior systemic therapy is permitted (except cisplatin or carboplatin)
Patients with small cell carcinoma must have progressed after at least one prior systemic therapy; patients with squamous cell carcinoma or adenocarcinoma may be previously untreated or have progressed after prior systemic therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen; NOTE: There is no maximum number of prior treatments allowed
Prior therapy is allowed
Patients with metastatic disease may have received prior nephrectomy and/or prior systemic therapy (no limit on number); their baseline pMRI would be performed prior to starting a new treatment
Prior systemic cancer therapy
No prior therapy for IDC or ILC
No prior therapy for disease under study
CRITERIA FOR SYSTEMIC THERAPY WITH ERLOTINIB