A Phase 1 interventional study of cisplatin and irinotecan hydrochloride in Unspecified Childhood Solid Tumor, Protocol Specific, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2013-07-02.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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.
PRIMARY 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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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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)
Exclusion Criteria:
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.
Drug: cisplatin · Drug: irinotecan hydrochloride · Drug: amifostine trihydrate · Other: pharmacological study
Given IV
Also known as: CACP, CDDP, CPDD, DDP
Given IV
Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E
Given IV
Also known as: ethiofos, Ethyol, gammaphos, WR-2721
Correlative studies
Also known as: pharmacological studies
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
Time frame: 6 weeks
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)