1 |
3 |
|
35 |
whole brain |
10 |
|
25 |
2 |
31 |
history of |
4 |
total body |
9 |
. |
3 |
3 |
2 |
> = 2 weeks must have elapsed for local palliative radiation therapy xrt small port and enrollment on study at least 24 weeks must have elapsed since |
2 |
pelvic |
7 |
> = 6 weeks prior to enrollment r n local palliative radiation therapy xrt small port > = 2 weeks |
2 |
4 |
1 |
> = 2 weeks must have elapsed since local palliative radiation therapy xrt small port > = 6 weeks must have elapsed since treatment with therapeutic doses of m iodobenzylguanidine mibg > = 3 months must have elapsed if |
1 |
to enrollment r n focal |
4 |
or total body irradiation > = 12 weeks prior to registration |
2 |
5 |
4 |
radiotherapy > = 2 weeks must have elapsed since local palliative radiotherapy xrt small port > = 3 months must have elapsed if |
1 |
|
4 |
tbi |
2 |
6 |
5 |
patients must have had their last fraction of r n craniospinal irradiation > = 3 months |
1 |
cranial |
3 |
tbi was received > = 6 weeks must have elapsed if other substantial bone marrow irradiation was given r n subjects shomcLd not have any clinically relevant ongoing complications from prior radiation therapy i . e . radiation esophagitis or other inflammation of the viscera |
1 |
7 |
6 |
inclusion criteria for stratum c patients must have had their last fraction of r n craniospinal irradiation > = 3 months |
1 |
to enrollment r n other substantial bone marrow |
2 |
tbi radiation to > = 50 of pelvis or craniospinal radiation > = 6 weeks must have elapsed if the patient has received other substantial bone marrow radiation |
1 |
8 |
7 |
at least 2 weeks must have elapsed since local radiation therapy xrt small port 3 months must have elapsed if |
1 |
to registration investigators are reminded to review potentially eligible cases to avoid confusion with pseudo progression r n had their last fraction of craniospinal |
2 |
tbi craniospinal xrt or if 50 radiation of pelvis 45 days must have elapsed if other substantial bone marrow radiation |
1 |
9 |
9 |
at least 2 weeks must have elapsed since local palliative radiation therapy xrt small port at least 6 weeks must have elapsed since treatment with therapeutic doses of metaiodobenzylguanidine mibg at least 3 months must have elapsed if |
1 |
chemotherapy or pelvic |
2 |
was given . |
1 |
10 |
10 |
the subject must have recovered from the acute toxic effects of all |
1 |
craniospinal xrt was received if > = 50 of the pelvis was irradiated or if total body |
1 |
tbi was received 6 weeks must have elapsed if other substantial bone marrow irradiation was given |
1 |
11 |
11 |
> = 2 weeks must have elapsed for local radiation therapy xrt small port > = 6 months must have elapsed if |
1 |
to registration patients must be 14 days for local palliative radiation therapy xrt small port 90 days must have elapsed if prior total body |
1 |
total craniospinal xrt or 50 radiation of pelvis within 6 months of receiving first dose of study drug |
1 |
12 |
12 |
patients must have had |
1 |
traumatic brain injury tbi craniospinal xrt or if > = 50 radiation of pelvis > = 6 weeks must have elapsed if other substantial bone marrow |
1 |
tbi was received at least 6 weeks must have elapsed if other substantial bone marrow irradiation was given |
1 |
13 |
13 |
external beam radiation therapy xrt at least 14 days after local palliative xrt small port at least 150 days must have elapsed if |
1 |
cranial or craniospinal xrt was received if 50 of the pelvis was irradiated or if total body |
1 |
tbi 12 weeks r n total body irradiation tbi 24 weeks |
1 |
14 |
14 |
> = 2 weeks wks for local palliative radiation therapy xrt small port > = 6 weeks must have elapsed since treatment with therapeutic doses of mibg > = 6 months must have elapsed if |
1 |
craniospinal xrt was received if more than 50 of the pelvis was irradiated or if total body |
1 |
including total body irradiation |
1 |
15 |
15 |
for all patients > = 4 weeks must have elapsed for local external beam radiation therapy xrt > = 6 months must have elapsed if |
1 |
therapy with the exception of alopecia . the following time must have elapsed from the last dose of the following medications to study enrollment r n myelosuppressive chemotherapy 14 days r n hematopoietic growth factors 7 days 14 days for nemcLasta r n biologic agent 7 days r n monoclonal antibody 3 half lives r n immunotherapy ie tumor vaccines 42 days r n palliative small port radiation therapy xrt 14 days r n substantial bone marrow xrt 6 weeks r n stem cell transplant or infusion without total body |
1 |
> = 18 gray gy > = 4 weeks for local radiation to primary tumor and > = 2 weeks prior to registration for focal irradiation to symptomatic metastatic sites |
1 |
16 |
18 |
patients must have had their last fraction of r n craniospinal irradiation > = 24 gray gy or total body irradiation > = 12 weeks |
1 |
radiation to > = 50 of the pelvis or if other substantial bone marrow |
1 |
tbi craniospinal xrt or if > = 50 radiation of pelvis at least 42 days must have elapsed if other substantial bone marrow bm radiation |
1 |
17 |
19 |
patient has received radiation therapy |
1 |
radiation therapy for treatment of their ependymoma external beam radiation therapy xrt must be > = 3 months prior to registration for craniospinal |
1 |
tbi craniospinal xrt or > = 50 radiation of pelvis > = 6 wks must have elapsed if other substantial bone marrow bm radiation |
1 |
18 |
21 |
subject who has received |
1 |
radiation to > = 50 of the pelvis or if substantial bone marrow |
1 |
patients with a history of prior radiation with field including the heart i . e . mantle will be excluded |
1 |
19 |
22 |
radiation therapy within 2 weeks |
1 |
radiotherapy rt at least four weeks since completion of whole brain |
1 |
tbi radiation to > = 50 of pelvis or craniospinal radiation > = 6 weeks must have elapsed if the patient has received other substantial bone marrow bm radiation > = 6 weeks for prior metaiodobenzylguanidine mibg therapy for patients with only one site of measurable or evaluable disease radiation must not have been given to that site unless that site has demonstrated clear progression after radiation or at least 2 months have elapsed since radiation and their remains evidence of viable tumor on biopsy |
1 |
20 |
23 |
radiation patients must have r n had their last fraction of local irradiation to primary tumor > = 12 weeks |
1 |
to study registration patients must have had their last fraction of local |
1 |
at least two weeks since completion of prophylactic cranial irradiation and to any other site . |
1 |
21 |
24 |
participants may have received |
1 |
total body or hemi body |
1 |
> = 2 weeks prior to enrollment r n > = 3 months since autologous bone marrow / stem cell transplant prior to enrollment |
1 |
22 |
26 |
radiation patients must have r n had their last fraction of local irradiation to primary tumor > = 12 months |
1 |
to randomization including stereotactic or partial brain |
1 |
to the primary tumor > = 3 months prior to registration their last fraction of craniospinal irradiation > = 24 gy or total body irradiation > = 3 months prior to registration or > = 6 weeks wks for the therapeutic doses of mibg patient has not received focal irradiation for symptomatic metastatic sites within 14 days prior to registration |
1 |
23 |
39 |
progressive intracranial ependymoma after |
1 |
prophylactic cranial |
1 |
or is schedmcLed for pelvic nodal irradiation |
1 |
24 |
44 |
patients must have had their last fraction of r n craniospinal irradiation > = 24 gy > = 3 months |
1 |
radiation cranial |
1 |
. whole brain irradiation within 4 weeks prior to randomization |
1 |
25 |
49 |
patients must have r n had their last fraction of local irradiation to primary tumor > = 12 weeks |
1 |
thoracic |
1 |
pci is allowed |
1 |
26 |
53 |
patients who have received |
1 |
mediastinal |
1 |
> = 24 gy > = 3 months prior to registration |
1 |
27 |
54 |
no |
1 |
whole / partial brain |
1 |
to > = 30 of bm reserves including total body irradiation regardless of the washout period |
1 |
28 |
58 |
any |
1 |
focal |
1 |
total body irradiation tbi or 50 radiation of pelvis 3 months prior to screening . focal irradiation 3 weeks prior to screening if radiation field involved a nontarget lesion 6 weeks prior to screening if radiation field involved a target lesion . note true disease progression following prior irradiation therapy must be confirmed by investigator prior to screening . bone marrow transplant < 6 months since allogeneic bone marrow transplant prior to screening . < 3 months since autologous bone marrow / stem cell transplant prior to screening . < 3 months since stem cell transplant sct or rescue without tbi with no evidence of gvhd prior to screening . radioisotopes fluorothymidine 18flt 72 hours prior to first dose of study drug |
1 |
29 |
59 |
patients must have had their last fraction of r n craniospinal irradiation total body irradiation tbi or > = 50 radiation of pelvis > = 3 months |
1 |
craniospinal |
1 |
to the area to be treated |
1 |
30 |
63 |
patients must not have received any |
1 |
intracavitary |
1 |
for any reason |
1 |
31 |
64 |
patients will be allowed to participate following single |
1 |
therapeutic radiation exposure to tissues for which protocol |
1 |
or stereotactic radiosurgery |
1 |
32 |
65 |
recurrent / progressive dipg stratum 1 patients must have had their last fraction of r n craniospinal irradiation or radiation to > = 50 of pelvis > = 3 months |
1 |
to registration r n had their last fraction of craniospinal |
1 |
prior total abdominal or whole liver radiation |
1 |
33 |
66 |
non progressed dipg stratum 2 patients must have had their last fraction of focal irradiation to the primary site > = 14 days |
1 |
neck radiotherapy that womcLd preclude re |
1 |
or gliadel wafers |
1 |
34 |
68 |
at least 60 days from |
1 |
abdominopelvic radiotherapy is allowed except for total body |
1 |
is anticipated is an exclusion criterion |
1 |
35 |
69 |
patients with |
1 |
melanoma treatment other than surgery or regional |
1 |
> = 42 days prior to enrollment r n local palliative irradiation small port > = 14 days |
1 |
36 |
71 |
history of extensive |
1 |
abdomino pelvic |
1 |
is allowed if > = 28 days prior to registration have elapsed since n the date of last treatment . |
1 |
37 |
72 |
has undergone chest irradiation within 12 weeks |
1 |
cns treatment with stereotactic radiotherapy whole brain |
1 |
are not eligible |
1 |
38 |
73 |
external radiation therapy xrt must not have received xrt within 3 months |
1 |
to enrollment patients must not have received local palliative |
1 |
administered > = 10 years prior no prior systemic therapy for anal cancer |
1 |
39 |
75 |
evidence or suspected recurrent or metastatic disease |
1 |
history of pelvic |
1 |
to lung fields |
1 |
40 |
76 |
patients receiving |
1 |
to randomization except palliative |
1 |
> = 6 weeks prior to enrollment r n local palliative radiation therapy xrt small port > = 4 weeks |
1 |
41 |
8 |
|
NA |
to study entry for craniospinal |
1 |
and stable without steroid requirement for 2 months or following 2 prior cns treatments with stereotactic radiotherapy whole brain irradiation and stable without steroid requirement for 4 months . |
1 |
42 |
16 |
|
NA |
brain |
1 |
to the primary site > = 42 days prior to enrollment r n local palliative irradiation other than previously irradiated primary site small port > = 14 days |
1 |
43 |
17 |
|
NA |
external beam |
1 |
or craniospinal irradiation |
1 |
44 |
20 |
|
NA |
re |
1 |
tbi making tmi not feasible |
1 |
45 |
25 |
|
NA |
|
NA |
of bone lesions |
1 |
46 |
27 |
|
NA |
|
NA |
> = 24 gy or total body irradiation or if > = 50 radiation of pelvis > = 8 weeks for local irradiation to primary tumor > = 2 weeks for focal irradiation for symptomatic metastatic sites |
1 |
47 |
28 |
|
NA |
|
NA |
is not allowed |
1 |
48 |
29 |
|
NA |
|
NA |
to the head or neck including any form of stereotactic irradiation |
1 |
49 |
30 |
|
NA |
|
NA |
or stereotactic radiosurgery for recurrent disease at the same tumor location intended for hfrt in this study |
1 |