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NCT00002601 · ClinicalTrials.gov registry record · Phase 2

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma

A Phase 2 study, sponsored by City of Hope Medical Center.

Completed
Registry status
Phase 2
Development phase
13
Enrollment target

NCT00002601: Completed Phase 2 study, sponsored by City of Hope Medical Center.

NCT00002601 is a Phase 2 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00002601, a Phase 2 study, has completed, sponsored by City of Hope Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
13 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy and peripheral stem cell transplantation in treating patients who have advanced or recurrent sarcoma.

Primary Outcome

Criteria for early termination of this feasibility study: \> 2 patients experience grade 4 or 5 hematologic toxicity or more that 3 patients experience grade 3 hematologic toxicity; \> 2 patients experience grade 3 hepatic or gastrointestinal toxicity or \> 3 patients are unable to receive the second cycle of treatment; \> 2 patients experience grade 5 toxicity related to treatment regimen.

Interventions

  • DRUG cisplatin
  • DRUG melphalan
  • DRUG ifosfamide
  • BIOLOGICAL filgrastim
  • DRUG doxorubicin hydrochloride

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 1994-09
Est. Completion 2014-09
Phase Phase 2
City of Hope Medical Center

582 total trials

What the finished NCT00002601 record still lists

NCT00002601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.

NCT00002601 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00002601 about?

NCT00002601 is a clinical study titled "Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumo...

What is the current status of trial NCT00002601?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 1994-09. Estimated completion is 2014-09.

What interventions are being tested in trial NCT00002601?

The interventions under investigation include: cisplatin (DRUG), melphalan (DRUG), ifosfamide (DRUG), filgrastim (BIOLOGICAL), doxorubicin hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00002601?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00002601's enrollment target sits among peer trials

13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00002601, the US trial registry maintained by the National Library of Medicine. NCT00002601 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.