Nanoparticle Albumin-Bound Rapamycin, Temozolomide, and Irinotecan Hydrochloride in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors

Conditions

• Childhood Solid Neoplasm
• Recurrent Malignant Solid Neoplasm
• Recurrent Primary Central Nervous System Neoplasm
• Refractory Malignant Solid Neoplasm
• Refractory Primary Central Nervous System Neoplasm

Eligibility Criteria

Sex

ALL

Age

12 Months - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Irinotecan Hydrochloride — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pharmacological Study — OTHER
  Correlative studies
• Sirolimus Albumin-bound Nanoparticles — DRUG
  Given IV
• Temozolomide — DRUG
  Given PO

Study Details

This phase I trial studies the side effects and best dose of nanoparticle albumin-bound rapamycin when given together with temozolomide and irinotecan hydrochloride in treating pediatric patients with solid tumors that have come back after treatment and a period of time during which the tumor could not be detected or has not responded to treatment. Nanoparticle albumin-bound rapamycin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as temozolomide and irinotecan hydrochloride, 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 nanoparticle albumin-bound rapamycin, temozolomide, and irinotecan hydrochloride may cause the cancer to stop growing or shrink for a period of time and may lessen the symptoms that are caused by the cancer.

Key Dates

Start date

Aug 15, 2017

Status verified

Jan 2025

Primary completion

Mar 31, 2022

Completion

Dec 31, 2024

Study Design

Enrollment

33 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (nab-rapamycin, temozolomide, irinotecan)
  Patients receive nanoparticle albumin-bound rapamycin IV over 30 minutes on days 1 and 8 beginning on cycle 1. Patients also receive temozolomide PO and irinotecan hydrochloride PO on days 1-5 beginning on cycle 2. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Patients With Cycle 1 and 2 Dose Limiting Toxicities Attributable to Nanoparticle Albumin-bound Rapamycin [ Time Frame: Up to 42 days ]

Locations (21)

Find similar trials in Birmingham, AL

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