Status:
COMPLETED
Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory Solid Tumors, Lymphoma, or Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Childhood Acute Promyelocytic Leukemia (M3)
Childhood Atypical Teratoid/Rhabdoid Tumor
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of vorinostat when given together with isotretinoin in treating young patients with recurrent or refractory solid tumors, lymphoma, or leu...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of vorinostat (SAHA) in young patients with recurrent or refractory solid tumors or lymphomas. II. Determine the MTD of SAHA adminis...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed\* diagnosis of 1 of the following:
- Recurrent or refractory solid tumor or lymphoma (for patients in group 1)
- Measurable or evaluable disease
- Recurrent or refractory leukemia (for patients in group 2)
- Greater than 25% blasts in the bone marrow (i.e., M3 bone marrow)
- Active extramedullary disease allowed except leptomeningeal disease
- Recurrent or refractory CNS tumor of 1 of the following types (for patients in group 3):
- Neuroblastoma
- Medulloblastoma/CNS primitive neuroectodermal tumor
- Atypical teratoid rhabdoid tumor
- No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
- No bone marrow involvement by disease (for patients in groups 1 and 3)
- No active CNS leukemia
- Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
- Performance status - Karnofsky 60-100% (for patients \> 10 years of age)
- Absolute neutrophil count ≥ 1,000/mm\^3 (for solid tumor patients)
- Platelet count ≥ 100,000/mm\^3\* (for solid tumor patients) (20,000/mm\^3\*\* for leukemia patients)
- Hemoglobin ≥ 8.0 g/dL (RBC transfusion allowed) (for solid tumor and leukemia patients)
- Triglycerides \< 300 mg/dL (for patients in group 3)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 5 times ULN
- Albumin ≥ 2 g/dL
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
- Creatinine based on age as follows:
- No greater than 0.8 mg/dL (for patients ≤ 5 years of age)
- No greater than 1.0 mg/dL (for patients 6 to 10 years of age)
- No greater than 1.2 mg/dL (for patients 11 to 15 years of age)
- No greater than 1.5 mg/dL (for patients over 15 years of age)
- Negative dipstick for protein OR \< 1,000 mg protein/24 hour urine collection (for patients in group 3)
- No evidence of gross hematuria (for patients in group 3)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Body surface area ≥ 0.5 m\^2
- Neurologic deficits in patients with CNS tumors must be stable for ≥ 1 week before study entry
- Able to swallow whole capsules
- No uncontrolled infection
- Skin toxicity \< grade 1 (for patients in group 3)
- Recovered from prior immunotherapy
- At least 7 days since prior hematopoietic growth factors
- At least 7 days since prior antineoplastic biologic agents
- At least 2 months since prior stem cell transplantation or rescue
- No evidence of active graft-versus-host disease
- No other concurrent biologic therapy or immunotherapy
- More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent chemotherapy
- Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for ≥ 7 days prior to study entry
- No concurrent dexamethasone for antinausea or antiemetic therapy
- Recovered from prior radiotherapy
- At least 2 weeks since prior local, palliative, small-port radiotherapy
- At least 3 months since prior total-body irradiation, radiotherapy to the craniospinal area, or radiotherapy to ≥ 50% of the pelvis
- At least 6 weeks since other prior substantial radiotherapy to the bone marrow
- No concurrent radiotherapy
- At least 2 weeks since prior valproic acid
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No concurrent enzyme-inducing anticonvulsants
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00217412
Start Date
August 1 2005
End Date
September 1 2009
Last Update
June 17 2014
Active Locations (1)
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1
Children's Oncology Group
Philadelphia, Pennsylvania, United States, 19104