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90Y DOTA/Retinoic Acid for Neuroblastoma and Neuroendocrine Tumor (NET)

NCT01048086 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-06-21

No results posted yet for this study

Summary

This study is for patients with neuroblastoma or a neuroendocrine tumor who have not been able to have standard therapy or have failed the first-line therapy. The purpose of this study is to assess the safety and effectiveness of the combination of retinoic acid and Onalta (Y-90-DOTA-tyr3-Octreotide) in treating neuroblastoma and neuroendocrine tumors.

Conditions

Interventions

DRUG

Retinoic Acid

160 mg, given orally, divided BID on Days 1-4 of each cycle for 4 cycles. Each cycle will be six weeks in duration. Dose will be adjusted to 5.33 mg/kg/day divided BID for children \<12 kg.

DRUG

Placebo

Placebo will be given in the same manner as retinoic acid in capsules that look identical.

Sponsors & Collaborators

  • Molecular Insight Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • University of Iowa

    lead OTHER

Principal Investigators

  • M Sue O'Dorisio, MD, PhD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01048086 on ClinicalTrials.gov