PAZIT Study for Children and Young Adults With Relapsed or Refractory Sarcoma

Part of paid clinical trials in Oakland, California.

Sponsor
University of California, San Francisco
Study ID
NCT03139331
Phase
PHASE1
Status
Completed

Conditions

  • Refractory Sarcoma
  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
6 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Pazopanib — DRUG
    Pazopanib will be administered orally as a tablet according to an assigned dose level per protocol. A cycle will be defined as 21 days. Drug dosing for the tablet formulation will be determined using a study-specific nomogram.
  • Irinotecan — DRUG
    Patients will be given irinotecan at a dose of 25 mg/m2/dose IV on days 1-5 of a 21-day cycle during Cycle 1. In subsequent cycles, irinotecan may be given intravenously at a dose of 25 to 37.5 mg/m2/dose or orally at a dose of 45 to 67.5 mg/m2/dose on days 1-5 of a 21-day cycle. Note that some patients enrolled on an earlier protocol version received 50 mg/m2/dose IV on days 1-5 of the first 21-day cycle and then either 50 mg/m2/dose IV or 90 mg/m2/dose orally for subsequent 21-day cycles. This higher dose level is no longer being given to newly enrolled subjects.
  • Temozolomide — DRUG
    Temozolomide will be given at a dose of 100 mg/m2/dose orally on days 1-5 of each 21-day cycle.

Study Details

This is the first study to evaluate the safety and clinical activity of the combination of oral pazopanib, intravenous or oral irinotecan, and oral temozolomide in pediatric and young adult patients with relapsed or refractory sarcomas. This study will use a 3 + 3 design for dose escalation (Part 1), followed by an expansion cohort (Part 2) at the recommended phase 2 dose level.

Key Dates

Start date
Jun 6, 2017
Status verified
Dec 2020
Primary completion
Oct 15, 2019
Completion
Sep 30, 2020

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pazopanib, irinotecan, temozolomide (PAZIT)
    Patients will receive daily oral pazopanib on days 1-21 in a 21-day cycle. This will be combined with intravenous or oral irinotecan and oral temozolomide on days 1-5. Dosing of irinotecan will be from 25 to 37.5 mg/m2/day for IV dosing or from 45 to 67.5 mg/m2/dose for oral dosing and oral temozolomide will be 100 mg/m2/day for dose levels at each assigned dose level. In the absence of disease progression or unacceptable toxicity, patients will receive cycles of therapy repeating every 21 days for a maximum of 12 months on study.

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: 3 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
UCSF Benioff Children's Hospital, OaklandOaklandCalifornia94609-
University of California, San FranciscoSan FranciscoCalifornia94143-
Dana-Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Oakland, CA

By research site
UCSF Benioff Children's Hospital, Oakland· Oakland, CAUniversity of California, San Francisco· San Francisco, CADana-Farber Cancer Institute· Boston, MA

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