A Phase 1 interventional study of wild-type reovirus and cyclophosphamide in Unspecified Childhood Solid Tumor, Protocol Specific, sponsored by National Cancer Institute (NCI). Completed at 27 sites in 2 countries. Open to participants aged 3 Years to 21 Years. Per ClinicalTrials.gov, last updated 2014-05-13.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
This phase I trial studies the side effects and the best dose of viral therapy in treating young patients with solid tumors that have come back or that have not responded to standard therapy. Some tumors have cells with a genetic weakness that makes them unable to fight off a virus called wild-type reovirus. The virus causes cells with this weakness to die, and may therefore be able to kill tumor cells without damaging normal cells. Cyclophosphamide is a drug used in chemotherapy that stops tumor cells from dividing and causes them to die. Giving wild-type reovirus together with cyclophosphamide may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of REOLYSIN (wild-type reovirus) administered as an intravenous infusion daily for 5 days, every 28 days to children with relapsed or refractory solid tumors.
II. To define and describe the toxicities of Reolysin in these patients. III. To define the toxicity and tolerability of combining Reolysin with oral cyclophosphamide in these patients.
IV. To characterize the pharmacokinetics (time course of viral clearance) of Reolysin in children with refractory cancer.
SECONDARY OBJECTIVES:
I. To define the antitumor activity of Reolysin within the confines of a phase I study.
II. To evaluate the development of neutralizing antibodies to Reolysin following intravenous administration of Reolysin alone and in combination with cyclophosphamide.
III. To assess the biologic activity of Reolysin.
OUTLINE: This is a dose-escalation study of wild-type reovirus.
Patients receive wild-type reovirus intravenously (IV) over 60 minutes once daily (QD) on days 1-5. Some patients also receive cyclophosphamide orally (PO) on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for up to 1 year.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 26 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min OR serum creatinine based on age and/or gender as follows:
Exclusion Criteria:
Patients receive wild-type reovirus IV over 60 minutes QD on days 1-5. Some patients also receive cyclophosphamide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Biological: wild-type reovirus · Drug: cyclophosphamide · Other: laboratory biomarker analysis · Other: pharmacological study
Given IV
Also known as: REOLYSIN
Given PO
Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Correlative studies
Correlative studies
Also known as: pharmacological studies
Maximum-tolerated dose (MTD), defined as the maximum dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT), graded using the NCI CTCAE v. 4.0
Time frame: Up to 28 days
Time course of viral clearance of wild-type reovirus
Summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
Time frame: Up to 3 months
Development of neutralizing antibodies to wild-type reovirus
Summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
Time frame: Up to 3 months
Disease response, assessed according to Response Evaluation Criteria in Solid Tumors (RECIST)
Will be reported descriptively.
Time frame: Up to 1 year
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)