Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children with refractory or advanced solid tumors who are receiving anticonvulsants.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: irinotecan hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Irinotecan in Patients With Refractory Solid Tumors Who Are Concomitantly Receiving Anticonvulsants |
| Study Start Date: | October 2000 |
OBJECTIVES:
- Determine the maximum tolerated dose of irinotecan in children with refractory or advanced solid tumors receiving anticonvulsants.
- Determine the dose-limiting toxicity of irinotecan in this patient population.
- Evaluate the pharmacokinetic behavior of this treatment regimen in these patients.
- Determine, preliminarily, the antitumor activity of this treatment regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to type of concurrent anticonvulsant (enzyme activating anticonvulsants vs valproic acid vs other anticonvulsants).
Patients receive irinotecan IV over 1 hour daily for 5 days. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 6 months for up to 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy refractory to conventional therapy or for which no conventional therapy exists
- Histologic confirmation not required for brain stem tumors
- Concurrently on anticonvulsants at a steady level for at least 2 weeks
PATIENT CHARACTERISTICS:
Age:
- 1-21 years old
Performance status:
- Karnofsky 50-100% (over 10 years of age)
- Lansky 50-100% (10 years of age or under)
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Neutrophil count at least 1,000/mm3
- Platelet count at least 100,000/mm3 (transfusion independent)
- Hemoglobin at least 8.0 g/dL (red blood cell transfusions allowed)
Hepatic:
- Bilirubin no greater than 1.5 times normal for age
- SGPT less than 5 times normal for age
- Albumin at least 2 g/dL
Renal:
- Creatinine no greater than 1.5 times normal for age OR
- Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal for age
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- No evidence of active graft-vs-host disease
- Neurologic deficits for CNS tumors stable for at least 2 weeks prior to study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 1 week since prior antineoplastic biologic therapy
- At least 6 months since prior allogeneic stem cell transplantation
- At least 1 week since prior growth factors
- No concurrent sargramostim (GM-CSF)
- No concurrent prophylactic growth factors during first course of study therapy
- Recovered from prior immunotherapy
Chemotherapy:
- At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea) and recovered
Endocrine therapy:
- Concurrent dexamethasone for CNS tumors with increased intracranial pressure allowed if dose stable or decreasing for at least 2 weeks prior to study
Radiotherapy:
- At least 2 weeks since prior local palliative radiotherapy (small part)
- At least 6 months since prior craniospinal radiotherapy
- At least 6 months since prior radiotherapy to at least 50% of pelvis
- At least 6 weeks since prior substantial bone marrow radiotherapy
- Recovered from prior radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent investigational agent
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Cancer Center and Beckman Research Institute, City of Hope | |
| Duarte, California, United States, 91010-3000 | |
| University of California San Diego Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027-0700 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Lucile Packard Children's Hospital at Stanford | |
| Palo Alto, California, United States, 94304 | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94143-0128 | |
| United States, Colorado | |
| Children's Hospital of Denver | |
| Denver, Colorado, United States, 80218 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Florida | |
| Shands Hospital and Clinics, University of Florida | |
| Gainesville, Florida, United States, 32610-100277 | |
| United States, Georgia | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Children's Memorial Hospital, Chicago | |
| Chicago, Illinois, United States, 60614 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Boston Floating Hospital Infants and Children | |
| Boston, Massachusetts, United States, 02111 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Mott Children's Hospital | |
| Ann Arbor, Michigan, United States, 48109-7821 | |
| Children's Hospital of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Cardinal Glennon Children's Hospital | |
| Saint Louis, Missouri, United States, 63104 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Columbia Presbyterian Hospital | |
| New York, New York, United States, 10032 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Children's Hospital Medical Center - Cincinnati | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, Tennessee | |
| Saint Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| United States, Wisconsin | |
| CCOP - Green Bay | |
| Green Bay, Wisconsin, United States, 54301 | |
| University of Wisconsin Hospital and Clinics | |
| Madison, Wisconsin, United States, 53792-0001 | |
| Midwest Children's Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Australia, South Australia | |
| Women's and Children's Hospital | |
| North Adelaide, South Australia, Australia, 5006 | |
| Australia, Victoria | |
| Royal Children's Hospital | |
| Parkville, Victoria, Australia, 3052 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6001 | |
| Canada, Ontario | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| McGill University Health Center - Montreal Children's Hospital | |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Study Chair: | Albert Moghrabi, MD | Hopital Sainte Justine |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00008424 History of Changes |
| Other Study ID Numbers: | CDR0000068410, COG-P9871, POG-P9871 |
| Study First Received: | January 6, 2001 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified childhood solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Anticonvulsants Irinotecan Camptothecin Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013