This trial is a Phase I/II multicenter safety/exploratory biomarker study in children with relapsed/refractory solid tumors.

Condition	Treatment or Intervention	Phase
Tumors	Drug: Temsirolimus	Phase I Phase II

Ages Eligible for Study:  1 Year   -   21 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subjects with a histological diagnosis of advanced cancer (solid tumors or central nervous system [CNS] tumors) with disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available (histological confirmation waived for brain stem gliomas and optic pathway tumors).
• Evaluable disease.
• At least 3 months since prior autologous or allogenic bone marrow transplantation (BMT) or stem cell transplant (SCT) at the time of study entry.
• Prior Radiotherapy: a) At least 2 weeks since prior local radiation therapy at the time of study entry.; b) At least 3 months since prior craniospinal radiotherapy at the time of study entry.; c) At least 6 months since prior radiotherapy to: whole abdomen or pelvis, whole lungs, >25% of bone marrow reserve, or total body irradiation at the time of study entry.
• At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) at the time of study entry.
• At least 3 weeks since prior immunotherapy at the time of study entry.
• At least 3 weeks since any other prior investigational therapy at the time of study entry. Investigational therapy is defined as treatment that is not approved for any indication.
• At least 7 days since prior growth factors at the time of study entry.
• Age: 1-21 years at the time of study entry.
• Lansky performance status 60%-100% for subjects aged 1 to 10 or Karnofsky performance status 60%-100% for subjects aged 11 to 21.
• Absolute Neutrophil Count (ANC) ≥ 1000/mm^3, platelet count ≥ 75,000/mm^3 (≥ 50,000/mm^3 for subjects with bone marrow involvement), and hemoglobin (Hgb) ≥ 8 g/dL (transfusion of packed red blood cells is permitted if subject is known to have bone marrow involvement).
• Adequate renal function: Serum creatinine concentration ≤ 3x normal for age.
• Adequate hepatic function: Bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x institutional ULN.
• Life expectancy of at least 2 months.
• Subjects of childbearing potential or with partners of childbearing potential must be willing to use a reliable method of birth control during entire course of study and for 12 weeks after study completion.
• Signed and dated, institutional review board (IRB) approved informed consent form (and assent form for subjects of appropriate age as required by each institution) before any screening procedures not considered standard-of-care are performed.

Exclusion Criteria:

• Subjects known to be human immunodeficiency virus (HIV) positive.
• Active infection or serious intercurrent illness.
• Subjects with known hepatitis C or known active hepatitis B.
• Pulmonary hypertension or pneumonitis.
• Any other major illness, which, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in this study.
• Concomitant therapy with any other investigational therapy.
• Major surgery within 6 weeks prior to study entry.
• Pregnant or lactating women.
• Known hypersensitivity to any of the components in the temsirolimus infusion or other medical reasons for not being able to receive adequate pre-medication.
• Unwillingness or inability to comply with procedures required in this protocol.

Indiana
      Riley Hospital for Children, Indianapolis,  Indiana,  46202,  United States; Recruiting
Pennsylvania
      Children’s Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Tennessee
      St Jude Children’s Research Hospital, Memphis,  Tennessee,  United States; Not yet recruiting

Study ID Numbers:  3066K1-139-US
Record last reviewed:  March 2005
Last Updated:  March 23, 2005
Record first received:  March 22, 2005
ClinicalTrials.gov Identifier:  NCT00106353
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08