Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
A Trial of Irinotecan and Cisplatin in Children With Refractory Solid Tumors
5 other identifiers
interventional
30
1 country
1
Brief Summary
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1999
CompletedFirst Submitted
Initial submission to the registry
March 7, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2003
CompletedFirst Posted
Study publicly available on registry
February 12, 2004
CompletedJuly 2, 2013
July 1, 2013
3.2 years
March 7, 2000
July 1, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
MTD defined as that dose level immediately below the dose level at which 2 patients out of 3 to 6 patients experienced dose-limiting toxicity using Common Toxicity Criteria version 2.0
6 weeks
Study Arms (1)
Treatment (cisplatin, irinotecan, amifostine)
EXPERIMENTALTreatment 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.
Interventions
Given IV
Given IV
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- Each patient must have a proven pathologic diagnosis of solid tumor; the tumor must be refractory to conventional therapies, or for which no effective therapy is known; patients with brain tumors are eligible, but they should not be receiving anticonvulsants; the requirement for histologic diagnosis can be waived for patients with brainstem gliomas
- Karnofsky \>= 50% for patients \> 10 years of age; Lansky play scale \>= 50% for children =\< 10 years of age; neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 2 weeks prior to study entry; patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score
- Life expectancy \>= 8 weeks
- Nutrition status \>= 3rd percentile weight for height and serum albumin \>= 2.5 g%
- Prior therapy: patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, and must be without significant systemic illness (e.g., infection, fever, mucositis, severe anorexia, and severe malnutrition)
- Myelosuppressive chemotherapy must not have been received within 3 weeks of entry on this study (six weeks if a prior nitrosourea)
- Biologic, anti-neoplastic agents must not have received at least 1 week
- Radiation \>= 2 weeks must have been elapsed from prior local radiation (small port); \>= 6 months must have been elapsed from prior craniospinal radiation or \>= 50% radiation of the pelvis; 6 weeks must have been elapsed from substantial bone marrow radiation
- Autologous or allogeneic BMT without TBI \>= 6 months must have been elapsed, with no evidence of GVH disease
- Growth factor(s) must not have been received within one week of entry on this study
- Steroids: patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 2 weeks prior to study entry
- ANC \>= 1,000/ul
- Hemoglobin \>= 8.0 g/dL
- Platelet count \>= 100,000/ul
- Bilirubin =\< 1.5 mg/dL
- +6 more criteria
You may not qualify if:
- Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- Patients who have uncontrolled infections are not eligible for this study
- Patients who are receiving any other chemotherapy or investigational agents are not eligible for this study
- Patients who are receiving anticonvulsants are not eligible for this study
- Patients who have received more than two prior chemotherapy regimens (single or multi-agent regimens)
- Patients who have had central axis radiation
- Patients with bone marrow involvement
- Patients who have had prior stem cell transplantation (with or without TBI)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
COG Phase I Consortium
Arcadia, California, 91006-3776, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abdul-Kader Souid
COG Phase I Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2000
First Posted
February 12, 2004
Study Start
December 1, 1999
Primary Completion
March 1, 2003
Last Updated
July 2, 2013
Record last verified: 2013-07