Sirolimus and Metronomic Chemotherapy in Treating Younger Patients with Recurrent and/or Refractory Solid or Central Nervous System Tumors

Active:	Yes
Cancer Type:	Solid Tumor	NCT ID:	NCT02574728
Trial Phases:	Phase II	Protocol IDs:	AFLACST1502 (primary) NCI-2015-01637 IRB00082488
Eligibility:	12 Months - 30 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Children's Healthcare of Atlanta - Egleston
NCI Full Details:	http://clinicaltrials.gov/show/NCT02574728

Summary

This phase II trial studies how well sirolimus and continuous or frequent treatment with low doses of chemotherapy work in treating younger patients with solid or central nervous system (CNS) tumors that have come back (recurrent) or have not responded to previous treatment (refractory). Biological therapies, such as sirolimus, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as etoposide, celecoxib, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sirolimus together with metronomic chemotherapy may be an effective treatment for solid and CNS tumors.

Objectives

PRIMARY OBJECTIVE:
I. To determine the objective response rate in children with recurrent and refractory solid tumors, including brain tumors, who are treated with continuous sirolimus administered orally once daily with celecoxib, and oral etoposide alternating every 21 days with oral cyclophosphamide in a 42 day cycle. (metronomic chemotherapy).

SECONDARY OBJECTIVES:
I. To determine time to progression in children with recurrent and refractory solid tumors, including brain tumors, who are treated with sirolimus administered orally once daily for 42 days in combination with metronomic chemotherapy.
II. To define and describe the toxicities of sirolimus administered in combination with metronomic chemotherapy administered on this schedule.
III. To evaluate the expression of pS6 kinase and other mechanistic target of rapamycin (mTOR) pathway components as measured in the blood and correlate this with time to progression and clinical response.
IV. To evaluate the expression of pS6 kinase and other mTOR pathway components as measured in tumor tissue and correlate this with time to progression and clinical response.

OUTLINE:
Patients receive sirolimus orally (PO) once daily (QD) and celecoxib PO twice daily (BID) on days 1-42, etoposide PO QD on days 1-21, and cyclophosphamide PO QD on days 22-42. Treatment repeats every 42 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.