Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01154816 : MLN8237 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia
PhasePhase 2
AgesMin: 1 Year Max: 21 Years
Eligibility
DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following:

- Histologically confirmed malignant solid tumor at original diagnosis or relapse

- Neuroblastoma

- Rhabdomyosarcoma (RMS)

- Osteosarcoma

- Ewing sarcoma/peripheral primitive neuroectodermal tumor

- Non-RMS soft tissue sarcoma

- Hepatoblastoma

- Malignant germ cell tumor

- Wilms tumor

- Rhabdoid tumor

- Morphology and immunophenotypic panel consistent with rhabdoid tumor
(required)

- Loss of INI1 confirmed by immunohistochemistry

- Molecular confirmation of tumor-specific bi-allelic INI1 loss/mutation
if INI1 immunohistochemistry is not available

- Histologically confirmed leukemia recurrent or refractory to ? 2 prior induction
or treatment regimens (must not be known to be refractory to red blood cell or
platelet transfusions)

- Acute lymphoblastic leukemia

- > 25% blasts in the bone marrow (M3 bone marrow), excluding known CNS
disease

- Acute myeloid leukemia

- ? 5 % blasts in the bone marrow (M2/M3 bone marrow), excluding known
CNS disease

- Radiographically measurable disease for solid tumors

- Patients with neuroblastoma who do not have measurable disease but have
iodine-123 metaiodobenzylguanidine (¹²³ I-MIBG)-positive lesions allowed

- None of the following qualify as measurable disease:

- Malignant fluid collections (e.g., ascites, pleural effusions)

- Bone marrow infiltration

- Lesions detected by nuclear medicine studies (e.g., bone, gallium, or PET
scans)

- Elevated tumor markers in plasma or cerebrospinal fluid

- Previously irradiated lesions that have not demonstrated clear progression
after radiotherapy

- No CNS disease (leukemia patients)

PATIENT CHARACTERISTICS:

- ECOG performance score (PS) 0-2

- Karnofsky PS 50-100% (for patients > 16 years of age)

- Lansky PS 50-100% (for patients ? 16 years of age)

- ANC ? 1,000/mm³

- ANC ? 750/mm³ (solid tumor and known bone marrow metastatic disease)

- Transfusion allowed

- Hemoglobin ? 8.0 g/dL (RBC transfusion allowed)

- Platelet count ? 100,000/mm³ (transfusion independent, > 7 days since platelet
transfusion )

- Platelet count ? 50,000/mm³ (solid tumor and known bone marrow metastatic
disease)

- Transfusion allowed

- Not refractory to RBC or platelet transfusions

- Creatinine clearance or radioisotope GFR ? 70 mL/min OR a serum creatinine based on
age and/or gender as follows:

- 0.6 mg/dL (1 to < 2 years of age)

- 0.8 mg/dL (2 to < 6 years of age)

- 1.0 mg/dL (6 to < 10 years of age)

- 1.2 mg/dL (10 to < 13 years of age)

- 1.5 mg/dL (male) and 1.4 mg/dL (female) (13 to < 16 years of age)

- 1.7 mg/dL (male) and 1.4 mg/dL (female) (? 16 years of age)

- Total bilirubin ? 1.5 times upper limit of normal (ULN)

- ALT ? 5.0 times ULN

- Serum albumin ? 2 g/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ? 3 months after
completion of study therapy

- Not unable to swallow capsules

- No uncontrolled infection

- No patient who, in the opinion of the investigator, may not be able to comply with
the safety monitoring requirements of the study

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Fully recovered from all prior chemotherapy, immunotherapy, or radiotherapy

- More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea)
(solid tumor patients)

- At least 14 days since prior cytotoxic therapy (leukemia patients)

- Patients who relapse during standard maintenance therapy are not required to
wait 14 days

- At least 24 hours since prior cytoreduction with hydroxyurea

- More than 7 days since prior growth factors (14 days for pegfilgrastim [Neulasta])

- At least 7 days since prior biologic agent (antineoplastic agent)

- At least 3 half-lives since prior monoclonal antibody therapy

- At least 2 weeks since prior local palliative radiotherapy (small port)

- At least 6 weeks since prior therapeutic doses of ¹²³ I-MIBG or other
substantial bone marrow irradiation

- At least 6 months since prior craniospinal radiotherapy, radiotherapy to ? 50%
of the pelvis, or total-body irradiation

- At least 3 months since stem cell transplantation with no evidence of active
graft-vs-host disease

- Concurrent corticosteroids allowed provided patient is on a stable or decreasing dose
for ? 7 days before study enrollment

- No other concurrent investigational drugs

- No other concurrent anticancer agents, including chemotherapy, radiotherapy, or
immunomodulating agents

- No concurrent daily benzodiazepine therapy

- No concurrent P-glycoprotein substrates (e.g., digoxin, cyclosporine, tacrolimus, or
sirolimus)
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01154816      |      Link to official Clinicaltrials.gov listing
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