Viral Therapy in Treating Young Patients With Relapsed or Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01240538|
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : May 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Childhood Solid Tumor, Protocol Specific||Biological: wild-type reovirus Drug: cyclophosphamide Other: laboratory biomarker analysis Other: pharmacological study||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Dose Escalation Study of Reolysin, a Replication Competent Reovirus, in Pediatric Patients With Relapsed or Refractory Solid Tumors|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||April 2014|
Experimental: Treatment (virus and chemotherapy)
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
Other Name: REOLYSINDrug: cyclophosphamide
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: pharmacological study
Other Name: 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 [ Time Frame: Up to 3 months ]Summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
- Development of neutralizing antibodies to wild-type reovirus [ Time Frame: Up to 3 months ]Summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
- Disease response, assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 1 year ]Will be reported descriptively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240538
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|Principal Investigator:||E. Anders Kolb||COG Phase I Consortium|