Status:
COMPLETED
Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Unspecified Childhood Solid Tumor, Protocol Specific
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, vincristine, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose and recommended phase II dose of irinotecan when administered with temozolomide and vincristine in young patients with refractory solid tum...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed\* malignant solid tumor, including brain tumor, at original diagnosis or relapse
- Refractory disease NOTE: \*Histologic confirmation not required for intrinsic brain stem tumors
- Measurable or evaluable disease
- No known curative therapy OR therapy proven to prolong survival with an acceptable quality of life exists
- No known bone marrow metastases
- PATIENT CHARACTERISTICS:
- Age
- 1 to 21
- Performance status
- Lansky 50-100% (for patients ≤ 10 years of age)
- Karnofsky 50-100% (for patients \> 10 years of age)
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3 (transfusion independent)
- Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed)
- Hepatic
- ALT ≤ 110 U/L (upper limit of normal \[ULN\] for ALT is 45 U/L)
- Bilirubin ≤ 1.5 times ULN
- Albumin ≥ 2 g/dL
- Renal
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
- 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 \> 15 years of age)
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Neurologic deficits in patients with CNS tumors must be stable for ≥ 1 week prior to study entry
- No uncontrolled infection
- No documented allergy to cephalosporins or dacarbazine
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Recovered from prior immunotherapy
- At least 3 months since prior stem cell transplantation or rescue without total-body irradiation
- No evidence of active graft-versus-host disease
- At least 7 days since prior antineoplastic biologic agents
- At least 7 days since prior hematopoietic growth factors
- No concurrent biologic therapy or immunotherapy
- No concurrent prophylactic filgrastim (G-CSF) during the first course of study treatment
- Chemotherapy
- Recovered from prior chemotherapy
- Prior temozolomide, vincristine, irinotecan, or topotecan allowed
- No prior coadministration of temozolomide and irinotecan
- No disease progression during treatment with either irinotecan or temozolomide
- More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
- No other concurrent chemotherapy
- Endocrine therapy
- Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for ≥ 7 days prior to study entry
- Radiotherapy
- Recovered from prior radiotherapy
- At least 6 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis
- At least 6 weeks since other prior substantial bone marrow radiotherapy
- At least 2 weeks since prior local palliative radiotherapy (small port)
- No concurrent radiotherapy
- Surgery
- Not specified
- Other
- No other concurrent investigational drugs
- No other concurrent anticancer therapy
- No concurrent enzyme-inducing anticonvulsants, including any of the following:
- Phenobarbital
- Phenytoin
- Carbamazepine
- Oxcarbazepine
- No concurrent administration of any of the following:
- Rifampin
- Voriconazole
- Itraconazole
- Ketoconazole
- Aprepitant
- Hypericum perforatum (St. John's wort)
- No concurrent treatment for clostridium difficile infection
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00138216
Start Date
October 1 2005
End Date
January 1 2011
Last Update
October 2 2023
Active Locations (18)
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1
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
Children's Hospital of Orange County
Orange, California, United States, 92868
3
Stanford Cancer Center
Stanford, California, United States, 94305-5824
4
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614