RST1321: Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Hydrochloride Before Surgery in Treating Patients With Newly Diagnosed Non-Rhabdomyosarcoma Soft Tissue Sarcomas That Can be Removed by Surgery

Pazopanib Neoadjuvant Trial In Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613) (ARST1321)

Category:

Solid Tumor

Diseases Treated:

Non-rhabdomyosarcoma soft tissue sarcoma

Eligibility Overview:

  • > 2 years at the time of the biopsy that established the diagnosis of NRSTS.
  • Participant has a NRSTS in the extremity or trunk.
  • Participant has adequate bone marrow function.
  • Participant has not had prior Anthracycline or Ifosfamide therapy.
  • Participant is not HIV-positive.

Description

In this study, researchers want to find out if they can combine a drug called Pazopanib with radiation or chemotherapy in patients with intermediate and high risk NRSTS (Non-Rhabdomyosarcoma Soft Tissue Sarcomas) and to see if this drug can improve survival in these patients. Two current standard therapies will be used in the study: chemotherapy and radiation used together, or radiation with surgery (when it is needed).

At the beginning of the study, researchers will need to adjust the dose of pazopanib to determine how much of the drug can be safely given in combination with either chemotherapy or radiation. Once they know the safest dose they will look at how well the standard treatments work against NRSTS when given alone or in combination with Pazopanib.

Pazopanib has been used in a small study in children with cancer but it is still considered investigational.

Objectives

  • To find out what effects (good and/or bad) pazopanib given with both chemotherapy and radiation therapy has on people with intermediate and high risk NRST.
  • To answer some biology and imaging research questions that might benefit future patients. These studies are described in detail later in this form.

Eligibility criteria, among others, include:

  • Participant is greater than 2 years at the time of the biopsy that established the diagnosis of NRSTS.
  • Participant’s BSA is greater than or equal to 0.5.
  • Participant has a NRSTS in the extremity or trunk
  • Participant is able to swallow whole tablets.
  • Participant has adequate bone marrow function.
  • Participant has a life expectancy of at least 3 months with appropriate therapy.
  • Participants of childbearing potential have a negative pregnancy test.
  • Participant has not had prior Anthracycline or Ifosfamide therapy.
  • Participant is not HIV-positive.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Alberto Pappo, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.