[c09aa8]: / clusters / 9knumclustersv2 / clust_1253.txt

Download this file

81 lines (80 with data), 11.6 kB

 1
 2
 3
 4
 5
 6
 7
 8
 9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
Patients with prior anthracycline therapy will be excluded
Any prior anthracycline or platinum based therapy at any time
Patient must have completed a minimum of weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
Patient must have progressed or be refractory to prior anthracycline-containing chemotherapy (e.g. R-CHOP, DA-EPOCH-R, etc)
Planned neoadjuvant treatment with anthracycline and taxane containing chemotherapy
LVEF within normal limits if patient received prior anthracycline therapy [Period ].
Patients who were previously treated with standard anthracycline- and/or taxane-based chemotherapy will be recruited for this study
Any patient with the diagnosis of locally advanced, unresectable or metastatic soft tissue or bone sarcoma (except GIST and Kaposis) from any site. A minimum of prior chemotherapy regimen, including adjuvant or neo-adjuvant therapy for the treatment of sarcoma. Patients eligible for an anthracycline should have received a prior anthracycline containing regimen. Patients who decline or are not eligible for anthracycline treatment may be considered for this protocol as a first line treatment. Patients with a diagnosis of liposarcoma should also have received eribulin if they received anthracycline-based therapy prior to eribulin. Patients with a diagnosis of myxoid liposarcoma should have received trabectedin. Patients with angiosarcoma should have received either taxol or docetaxel. Patients must have measurable disease defined as at least lesion >= cm in the greatest dimension
Have had prior therapy (administered in the neoadjuvant, adjuvant, and/or metastatic setting) with an anthracycline, a taxane, and capecitabine (prior anthracycline can be omitted if not medically appropriate or contraindicated for the patient).
Participants that have received prior anthracycline therapy if the participant is to be enrolled in the doxorubicin combination arm.
No prior treatment with an anthracycline and taxane
(For cohort B only): Patients must have at least and no more than weeks between anthracycline-based therapy and start of treatment with mirvetuximab soravtansine
An anthracycline containing chemotherapy regimen
Prior systemic therapy with an anthracycline for any indication
Previous therapy for any malignancy with an anthracycline or taxane for Cohorts A and B and carboplatin for Cohort A
Patients with a total lifetime anthracycline exposure exceeding the equivalent of mg/m^ of daunorubicin
Has prior treatment using an anthracycline
Patients who have received any other previous antitumor therapies (other than anthracycline-based neoadjuvant chemotherapy for the current cancer event)
Subjects requiring daily corticosteroids, other than those given as premedication for the anthracycline-based chemotherapy
Patients must have received at least one dose of an anthracycline based neoadjuvant regimen; patients are eligible if therapy was discontinued due to disease progression or therapy intolerance
Patients with less than a . cm measurable residual disease after neoadjuvant anthracycline based chemotherapy
Subjects with a history of tumor progression within days of anthracycline administration are not eligible. However, subjects who have previously received an anthracycline and subsequently relapse greater than days after their most recent prior dose of anthracycline will be eligible.
No more than prior induction regimens (excluding prior HSCT) in their first line treatment and one must have included cytarabine with an anthracycline (or anthracenedione)
Received at least one dose of an anthracycline-based NACT; patients are eligible if therapy was discontinued due to disease progression or therapy intolerance
At least . cm of measurable residual disease after neoadjuvant anthracycline-based chemotherapy
Prior anthracycline, platinum salt, or taxane for any malignancy
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: If a patient has received anthracycline chemotherapy after enrollment, they must have demonstrated adequate cardiac function at any time following latest administration of an anthracycline chemotherapy (does NOT need to be within hours of T cell infusion) defined as shortening fraction > % by echocardiogram or an ejection fraction > % by MUGA
Have previously received any anthracycline outside the protocol
Patients >= are eligible if not a candidate for standard cytarabine plus anthracycline chemotherapy as determined by Kantarjians score; patients younger than may also be included if felt not to be a candidate for intensive anthracycline plus cytarabine based chemotherapy
Previous treatment must include treatment with a single line of chemoimmunotherapy containing an anthracycline and a CD-targeted agent
Subjects have received at least but no more than cycles of first-line anthracycline or ifosfamide containing systemic anti-cancer therapy regimen
Have received first-line systemic anti-cancer therapy with an agent other than anthracycline or ifosfamide
Patients for whom anthracycline, paclitaxel or antibody therapies are contraindicated: \r\n* Hypersensitivity reactions to any of the medications or to humanized monoclonal antibodies \r\n* History of congestive heart failure \r\n* Myocardial infarction within the past months \r\n* Pre-existing peripheral neuropathy >= grade \r\n* Prior anthracycline therapy with >= cumulative dose of mg/m^
Prior exposure to PLD or anthracycline therapy.
Previous therapy with anthracycline, taxanes, carboplatin, trastuzumab, or other HER targeted therapies for any malignancy
Prior anthracycline or taxane
Patients must be able to receive taxane and/or anthracycline based chemotherapy
Patients must not have received previous systemic anthracycline (intravesical anthracycline is allowed)
Current anthracycline use
Must have progressed following or have been unable to tolerate at least one prior anthracycline or alkylating agent containing regimen (with or without anti-CD).
Patients must have no prior radiation therapy to >= % of the bone marrow for prior systemic anthracycline therapy; prior intravesical anthracycline therapy for non-muscle invasive urothelial carcinoma of the bladder is permitted
Prior anthracycline therapy
Prior taxane or anthracycline chemotherapy for malignancy
Has received a prior anthracycline chemotherapy either for ovarian cancer treatment or another previous malignancy
For stratum A, patients must not have received prior anthracycline-based therapy (prior treatment with non-anthracyclines is permitted)
For stratum C, patients must have received prior anthracycline therapy anthracycline (or have a contraindication to anthracycline) or gemcitabine-based therapy (or have a contraindication to gemcitabine)
Prior anthracycline therapy
Patients who are high risk for developing the following anthracycline, paclitaxel, trastuzumab or pertuzumab related toxicities including:\r\n* History of congestive heart failure, myocardial infarction or cardiomyopathy, uncontrolled hypertension despite adequate medications\r\n* Pre-existing peripheral neuropathy >= grade \r\n* Prior anthracycline therapy\r\n* Known hypersensitivity to any of the study medications\r\n* Patients older than age due to increased risk of cardiotoxicity
Prior anthracycline use >= mg/m
Participants who have previously received doxorubicin, any other anthracycline chemotherapy or bevacizumab
Patents who received an anthracycline prior to enrollment must have an ejection fraction ? %
For patients with history of anthracycline exposure or coronary artery disease co-management by cardiology to optimize cardioprotective medications will be required prior to Tosedostat initiation.
A minimum of and a maximum of prior chemotherapy regimens, including adjuvant and neo-adjuvant therapy for the treatment of sarcoma; patients eligible for an anthracycline should have received a prior anthracycline containing regimen; patients who decline or are not eligible for anthracycline treatment may be considered for this protocol as a first line treatment
Must not have received an excessive cumulative dose of anthracycline
The patient has been exposed to >= mg/m^ of anthracycline
Prior anthracycline exposure: Patients must have less than mg/m lifetime exposure of anthracycline chemotherapy. (See Appendix II for calculation worksheet)
days for nitrosureas, mitomycin C, and liposomal anthracycline
Subjects who received prior anthracycline therapy
an anthracycline containing chemotherapy regimen
Prior anthracycline therapy
Prior exposure to the an anthracycline.
Prior extensive anthracycline exposure
Previous history of exposure to an anthracycline compound.
Treated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and additional cytotoxic chemotherapy regimen
Treated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and additional cytotoxic chemotherapy regimen with less than weeks from last dose of systemic anticancer therapy, radiation therapy, or therapy with any investigational agent
Prior anthracycline exposure: patients must have had less than mg/m^ lifetime exposure of anthracycline chemotherapy
Has received prior anthracycline therapy
Are unable to receive anthracycline therapy due to previous toxicity.
Subject must have previously received or be intolerant to anthracycline based therapy for advanced (metastatic or inoperable) disease. Subjects who received neoadjuvant/adjuvant anthracycline based therapy and progressed within months of completion of therapy will be eligible
Patients who are receiving therapy with an anthracycline
Previous anthracycline exposure
Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or Taxotere-Adriamycin-Cytoxan [TAC])
Allowable planned chemotherapy regimens (with or without ovarian suppression) are:\r\n* cycles of a taxane (T) anthracycline (A) and cyclophosphamide (C)\r\n* cycles of an anthracycline and cyclophosphamide plus cycles of a taxane\r\n* cycles of a taxane plus a platinum analogue with or without one or more human epidermal growth factor receptor (HeR-) targeted therapies such as trastuzumab +/- pertuzumab\r\n* cycles of an anthracycline plus a taxane\r\n* cycles of cyclophosphamide, an anthracycline and fluorouracil
Patients current chemotherapy treatment plan must include at least course of:\r\n* Cisplatin at ? mg/m/dose\r\n* Ifosfamide plus etoposide or doxorubicin or\r\n* Cyclophosphamide plus an anthracycline
Patient must have a lifetime cumulative anthracycline dose of >= mg/m^ DOXOrubicin equivalent without the protection of dexrazoxane (Zinecard) therapy; the anthracycline dose threshold must be met as part of the treatment of a cancer that was diagnosed at < years of age\r\n* Note: Institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) can be used to document lifetime receipt of anthracycline dose
Scheduled to receive anthracycline-based chemotherapy therapy
Patients not eligible for chemotherapy with taxane and/or anthracycline based chemotherapy regimens
Patient must have completed a minimum of weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
Have either received prior anthracycline treatment or have a reason not to receive anthracycline in the judgment of their treating physician
an anthracycline containing chemotherapy regimen