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| Sponsor: | Pediatric Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004919 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of irinotecan and cisplatin with or without amifostine in treating children who have solid tumors that have not responded to previous therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: amifostine trihydrate Drug: cisplatin Drug: irinotecan hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Trial of Irinotecan and Cisplatin in Children With Refractory Solid Tumors |
| Study Start Date: | December 1999 |
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of irinotecan when administered with cisplatin, with or without amifostine, to children with refractory solid tumors. II. Determine the dose limiting toxicities of the combination of irinotecan and cisplatin, with and without amifostine, in this patient population. III. Determine the pharmacokinetics of cisplatin with and without amifostine in these patients. IV. Quantify the leukocyte DNA-platinum adduct formation, with and without amifostine, and correlate it with response and toxicity in these patients. V. Determine the safety and efficacy of the doses and schedules of administration to be used in phase II clinical trials.
OUTLINE: This is a dose escalation study of irinotecan. Treatment A: Patients receive cisplatin IV over 1 hour followed immediately by irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 6 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Treatment B: Patients receive therapy as in treatment A. In addition, amifostine IV is administered over 15 minutes immediately before cisplatin. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Once the MTD of treatment A is determined, additional patients are accrued to determine the MTD of treatment B. If myelosuppression is the dose limiting toxicity of treatment A, then stratum 1 closes and stratum 2 opens and these patients with less prior therapy receive treatment A. Treatment B is then only open to stratum 3 patients. Patients are followed every 6 months for 4 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2.5 years.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed solid tumor that is refractory to standard therapy or for which no effective therapy exists Brainstem gliomas allowed without histologic diagnosis Brain tumors allowed provided not receiving anticonvulsants Strata 2 and 3: No bone marrow involvement
PATIENT CHARACTERISTICS: Age: 1 to 21 Performance status: Karnofsky 50-100% for patients over 10 years of age OR Lansky 50-100% for patients 10 years of age and under Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Hemoglobin at least 8.0 g/dL Platelet count at least 100,000/mm3 Hepatic: Albumin at least 2.5 g/dL Bilirubin no greater than 1.5 mg/dL SGPT no greater than 2 times upper limit of normal Renal: Creatinine normal for age OR GFR normal for age Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception If CNS tumor, neurologic deficits relatively stable for at least 2 weeks Must be at least third percentile weight for height No concurrent significant systemic illness (e.g., infection, fever, mucositis, severe anorexia, and severe malnutrition) No uncontrolled infections No evidence of graft versus host disease
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior biologic therapy and recovered At least 6 months since prior autologous or allogeneic bone marrow transplantation without total body irradiation (TBI) At least 1 week since prior growth factors Strata 2 and 3: No prior stem cell transplantation (with or without TBI) Chemotherapy: At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered At least 1 week since prior antineoplastic agents No other concurrent chemotherapy Strata 2 and 3: No more than 2 prior chemotherapy regimens (single or multiagent) Endocrine therapy: If receiving dexamethasone for CNS tumors, must be on stable or decreasing dose for at least 2 weeks Radiotherapy: At least 2 weeks since prior local radiation (small port) At least 6 months since prior craniospinal radiation At least 6 months since prior radiation to at least 50% of pelvis At least 6 weeks since prior substantial bone marrow radiation Recovered from prior radiotherapy Strata 2 and 3: No prior central axis radiotherapy Surgery: Not specified Other: No other concurrent investigational agents No other concurrent anticancer therapy No concurrent anticonvulsants
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027-0700 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5408 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| City of Hope National Medical Center | |
| Duarte, California, United States, 91010 | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94143-0128 | |
| University of California San Diego Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Florida | |
| University of Florida Health Science Center | |
| Gainesville, Florida, United States, 32610-0296 | |
| 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 | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| 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 | |
| Children's Hospital of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0752 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Cardinal Glennon Children's Hospital | |
| Saint Louis, Missouri, United States, 63104 | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Columbia Presbyterian Hospital | |
| New York, New York, United States, 10032 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| 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 | |
| Children's Hospital of Columbus | |
| Columbus, Ohio, United States, 43205-2696 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73190 | |
| 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 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| Texas Children's Cancer Center | |
| Houston, Texas, United States, 77030-2399 | |
| 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 | |
| Primary Children's Medical Center | |
| Salt Lake City, Utah, United States, 84113 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| United States, Wisconsin | |
| Midwest Children's Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| 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: | Abdul Kader Souid, MD, PhD | State University of New York - Upstate Medical University |
More Information
| Study ID Numbers: | CDR0000067601, POG-9970, CCG-P9970 |
| Study First Received: | March 7, 2000 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004919 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified childhood solid tumor, protocol specific drug/agent toxicity by tissue/organ |
|
Radiation-Protective Agents Molecular Mechanisms of Pharmacological Action Amifostine Antineoplastic Agents Irinotecan Physiological Effects of Drugs Enzyme Inhibitors Protective Agents |
Camptothecin Pharmacologic Actions Neoplasms Cisplatin Radiation-Sensitizing Agents Therapeutic Uses Antineoplastic Agents, Phytogenic |
