Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I Study of Temozolomide, Oral Irinotecan, and Vincristine for Children With Refractory Solid Tumors
Verified date | February 2014 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and vincristine in treating young patients with refractory solid tumors.
Status | Completed |
Enrollment | 42 |
Est. completion date | January 2011 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 21 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Hopital Sainte Justine | Montreal | Quebec |
Canada | Hospital for Sick Children | Toronto | Ontario |
United States | Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania |
United States | Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham | Alabama |
United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Children's Memorial Hospital - Chicago | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas |
United States | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
United States | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota |
United States | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York |
United States | Children's Hospital of Orange County | Orange | California |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Oregon Health and Science University Cancer Institute | Portland | Oregon |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington |
United States | Stanford Cancer Center | Stanford | California |
United States | SUNY Upstate Medical University Hospital | Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
Wagner LM, Perentesis JP, Reid JM, Ames MM, Safgren SL, Nelson MD Jr, Ingle AM, Blaney SM, Adamson PC. Phase I trial of two schedules of vincristine, oral irinotecan, and temozolomide (VOIT) for children with relapsed or refractory solid tumors: a Childre — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine maximum tolerated dose (MTD) of oral irinotecan | To estimate the maximum tolerated dose (MTD) of oral irinotecan administered on two different schedules together with fixed-dose temozolomide and vincristine in children with refractory solid tumors or brain tumors | length of study | |
Secondary | To preliminarily define the antitumor activity | To preliminarily define the antitumor activity of this drug combination within the confines of a Phase 1 study. | Length of study |
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