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NCT00288067 · ClinicalTrials.gov registry record · Phase 1

Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Terminated
Registry status
Phase 1
Development phase
32
Enrollment target

NCT00288067: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00288067 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00288067, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).

TERMINATED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

This phase I/II trial is studying the side effects and best dose of fenretinide and to see how well it works when given together with rituximab in treating patients with B-cell non-Hodgkin lymphoma. Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving fenretinide together with rituximab may kill more cancer cells.

Primary Outcome

A group of 3 patients would start treatment ast the dose of 900mg/m\^2 BID, and if none of the 3 experienced a DLT, another 3 would then be treated at that dose. Dose Limiting Toxicity was defined as any related toxicity of grade 4 or 5 on or before the completion of 4 weeks of therapy. Per response evaluation criteria 1999 Cheson Response Criteria for Malignant Lymphoma (CHESON99) for target lesions assessed by either CT or MRI: Complete Response (CR): Complete disappearance of all measurable

Interventions

  • DRUG rituximab
  • DRUG fenretinide

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2005-10
Est. Completion 2013-07
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

Why NCT00288067 stopped before completion

NCT00288067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

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

NCT00288067 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00288067 about?

NCT00288067 is a clinical study titled "Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma". This phase I/II trial is studying the side effects and best dose of fenretinide and to see how well it works when given together with rituximab in treating patients with B-cell non-Hodgkin lymphoma. Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of cancer ...

What is the current status of trial NCT00288067?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2005-10. Estimated completion is 2013-07.

What interventions are being tested in trial NCT00288067?

The interventions under investigation include: rituximab (DRUG), fenretinide (DRUG).

Who is sponsoring clinical trial NCT00288067?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00288067's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 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 NCT00288067, the US trial registry maintained by the National Library of Medicine. NCT00288067 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.