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|NCT02115139 : GEM STUDY: Radiation And Yervoy in Patients With Melanoma and Brain Metastases|
|Ages||Min: 18 Years Max: N/A|
1. Willing and able to give written informed consent.
2. Histologic diagnosis of melanoma.
3. First episode of radiological evidence of brain metastases
4. Be over the age of 18 years old
5. Radiation Therapy Oncology Group-recursive partitioning analysis (RTOG-RPA) class 2
6. Karnofsky performance status (PS) more than 70%
7. Barthel Index of Activities of Daily Living more than 10
8. Measurable disease (mWHO criteria).
9. Adequate organ function as determine by the following criteria:
- White blood count (WBC) more or equal to 2000/ microliter (uL)
- Absolute neutrophil count (ANC) more than 1.5 x 109/L.
- Platelet count more than 75 x 109/L.
- Hemoglobin more than 9 g/dL. If the patient received a red blood count (RBC)
transfusion, the required value of hemoglobin should be met at least 1 week
after the most recent transfusion.
- Serum creatinine less or equal to 2.0 x upper limit of normal (ULN).
- Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT)
less or equal to 2.5 x ULN for patients without liver metastasis, or less or
equal to 5 times for liver metastases.
- Total bilirubin less or equal 2.0 x ULN, (except patients with Gilbert's
Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
10. Persons of reproductive potential must agree to use an adequate method of
contraception throughout treatment and for at least 26 weeks after ipilimumab is
1. Patients with melanoma and brain metastases with any of the following
- Documented evidence of prior progression of melanoma to an ipilimumab-containing
regimen (i.e. received at least 2 doses of ipilimumab for either advanced
disease or in the adjuvant setting and the disease progressed/relapsed
(according to mWHO criteria) within 24 weeks since the first dose of ipilimumab)
- Prior radiation therapy to the brain
- Other prior antineoplastic therapies for brain metastases.
- Patients with cerebral metastases as the only location of the disease, for which
local therapy (neurosurgery, radiosurgery) could achieve a disease-free status
- Patients with a rapid clinical deterioration, or with risk of herniation, or who
require unstable ascending dosing of supportive medication in the last week
-including anti-convulsivants, steroids and analgesics-, or who require
dexamethasone more than 16 mg/d (or other glucocorticoid at an equipotent dose),
or with a high lactate dehydrogenase (LDH) more than 2 x ULN.
2. Any other malignancy form which the patient has been disease-free for less than 5
years, with the exception of adequately treated and cured basal or squamous cell skin
cancer, superficial bladder cancer or carcinoma in situ of the cervix, or incidental
3. Uncontrolled diabetes mellitus (HbA1c more than 9 %)
4. Autoimmune disease other than vitiligo or past thyroiditis under substitutive hormone
therapy: Patients with a history of inflammatory bowel disease, including ulcerative
colitis and Crohn's Disease, are excluded from this study, as are patients with a
history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive
sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg,
Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g.
Guillain-Barre Syndrome and Myasthenia Gravis).
5. Other chronic intestinal diseases associated with diarrhea.
6. Active infection or other serious illness or medical condition.
7. Known active or chronic infection with HIV, Hepatitis B, or Hepatitis C.
8. Concomitant therapy with any of the following: interleukin-2 (IL-2), interferon, or
other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive
agents; other investigation therapies; or chronic use of systemic corticosteroids
(used for the management of non-cancer related illnesses), either concomitantly or
during the last 30 days prior to the beginning of the treatment.
9. Any experimental therapy administered in the past 30 days prior to the beginning of
10. Any non-oncology vaccine therapy used for the prevention of infectious diseases (for
up to 4 weeks prior to or after any dose of blinded study drug) (see definitions in
11. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (eg, infectious) illness.
12. Any other general, medical or psychological conditions which in the opinion of the
investigator will make the administration of ipilimumab hazardous, or that would
preclude appropriate informed consent or compliance with the protocol, or obscure the
interpretation of eventual adverse events (AEs).
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