Status:
TERMINATED
Temsirolimus and Valproic Acid in Treating Young Patients With Relapsed Neuroblastoma, Bone Sarcoma, or Soft Tissue Sarcoma
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Neuroblastoma
Eligibility:
All Genders
2-18 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs such as temsirolimus and valproic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Valproic acid may also stop the growth of solid tumor...
Detailed Description
OBJECTIVES: Primary * To identify the maximum-tolerated dose of temsirolimus in combination with valproic acid in highly pretreated pediatric patients with refractory solid tumors. Secondary * To ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant solid tumor at original diagnosis, including the following:
- Neuroblastoma
- Bone sarcomas (primary neuroectodermal tumors/ Ewing sarcoma (PNET/ES), osteosarcoma)
- Soft tissue sarcomas (rhabdosarcoma and related tumors)
- Histologically confirmed of relapsed disease is highly recommended but not mandatory
- Measurable disease according to RECIST
- Refractory or progressive disease after ≥ 1 and ≤ 4 prior chemotherapy regimens
- Patients with neuroblastoma, PNET/ES, or rhabdosarcoma must have failed a cyclophosphamide/topotecan-containing regimen
- Stem cell transplantation, including preparative regimen and post-transplant immunotherapy, is considered to be 1 regimen
- PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 50-100% (or Lansky PS 50-100%)
- Life expectancy ≥ 8 weeks
- ANC ≥ 750/mm\^3
- Platelet count ≥ 75,000/mm\^3 (transfusion independent)
- Hemoglobin 8.0 g/dL (may receive RBC transfusions)
- Patients with tumor metastatic to bone marrow are allowed to receive transfusions to maintain hemoglobin and platelet counts
- Serum creatinine normal
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin \< 1.0 mg/dL (if total bilirubin \> 2.0 mg/dL)
- ALT \< 5 times ULN
- Negative pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Families must be able to give consent in English or Spanish
- No allergy to H1 antihistamines
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 2 weeks since prior chemotherapy, immunotherapy, or radiotherapy and recovered
- No concurrent anticonvulsants, including valproic acid
- No concurrent strong inducers or inhibitors of CYP3A4, including grapefruit juice
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01204450
Start Date
November 1 2009
End Date
March 1 2013
Last Update
December 23 2016
Active Locations (2)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
2
Carolina Healthcare System
Charlotte, North Carolina, United States