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NCT01998529 · ClinicalTrials.gov registry record · Phase 1

Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
7
Enrollment target

NCT01998529: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT01998529 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01998529, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
7 participants
Enrollment target

Study Summary

The goal of this clinical research study is to find the highest tolerated dose of heated cisplatin that can be given to patients with lung tumors. The safety of this drug will also be studied.

Primary Outcome

If 2 dose limiting toxicities (DLTs) are observed at a given dose level, MTD has been exceeded. Dose level below expanded to a total of 6 patients and if \</= 1 out of 6 patients experience a DLT at this dose level, this will be defined as the MTD. Dose limiting toxicity may occur at any time during the initial hospitalization before discharge following the HITC. The dose limiting toxicity is defined two ways. Hematologic DLT is defined as Grade IV neutropenia, anemia, or thrombocytopenia. Non-

Interventions

  • DRUG Cisplatin
  • DRUG Amifostine

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2014-08-20
Est. Completion 2020-08-25
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01998529 record still lists

NCT01998529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 2 interventions - of which Cisplatin is the first listed.

NCT01998529 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01998529 about?

NCT01998529 is a clinical study titled "Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy". The goal of this clinical research study is to find the highest tolerated dose of heated cisplatin that can be given to patients with lung tumors. The safety of this drug will also be studied.

What is the current status of trial NCT01998529?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2014-08-20. Estimated completion is 2020-08-25.

What interventions are being tested in trial NCT01998529?

The interventions under investigation include: Cisplatin (DRUG), Amifostine (DRUG).

Who is sponsoring clinical trial NCT01998529?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01998529's enrollment target sits among peer trials

7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01998529, the US trial registry maintained by the National Library of Medicine. NCT01998529 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.