RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
EpicentRx, Inc.
Study ID
NCT04525014
Phase
PHASE1
Status
Terminated

Conditions

  • Brain Tumor, Pediatric
  • Brain Tumor, Recurrent
  • Central Nervous System Neoplasms
  • Unspecified Childhood Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • RRx-001 — DRUG
    RRx-001 will be administered every 3 weeks via intravenous infusion at three dose levels: 0.5 mg/m2 (Max 1 mg), 1 mg/m2 (Max 2 mg), and 2 mg/m2 (Max 4 mg).
  • Temozolomide — DRUG
    100 mg/m2 (children ≥0.5 m2) or 3 mg/kg (children \<0.5 m2) daily for 5 days beginning on day 1 of each cycle
  • Irinotecan — DRUG
    90 mg/m2 taken orally daily for 5 days administered 1 hour after temozolomide

Study Details

The PIRATE study tests the experimental drug RRx-001 in combination with 2 chemotherapy drugs that are commonly used in patients with cancer. RRx-001 has been used alone and with other anti-cancer medicines in adults. However, the investigators do not know what effects it will have in children and young adults.

Key Dates

Start date
Jan 26, 2023
Status verified
Oct 2024
Primary completion
Jul 29, 2024
Completion
Jul 29, 2024

Study Design

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

Arms

  • Experimental: RRx-001, Temozolomide and Irinotecan

Primary Outcome Measure

Recommended phase 2 dose [ Time Frame: 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Children's Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
Texas Children's Cancer Center· Houston, TX

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