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COMPLETED Phase 2

Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma

NCT00085423 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with high-dose interleukin-2 works in treating patients with metastatic melanoma.

Conditions Studied

Interventions

  • DRUG cyclophosphamide
  • DRUG fludarabine phosphate
  • BIOLOGICAL aldesleukin
  • BIOLOGICAL sargramostim

Study Locations (1)

New Hampshire

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center — Lebanon

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2004-02
Est. Completion 2010-02
Phase Phase 2

Sponsor

Dartmouth-Hitchcock Medical Center

396 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00085423

The ClinicalTrials.gov registry entry for NCT00085423 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 396 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Melanoma (Skin) appearing as the primary indexed condition, and to 4 interventions — of which cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00085423 reports 1 study location spanning 1 distinct geographic area — top geographies include New Hampshire. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00085423 about?

NCT00085423 is a clinical study titled "Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma". RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells and may help a person's immune system recover from the s...

What is the current status of trial NCT00085423?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2004-02. Estimated completion is 2010-02.

What conditions does trial NCT00085423 study?

This clinical trial studies the following conditions: Melanoma (Skin). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00085423?

The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), aldesleukin (BIOLOGICAL), sargramostim (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00085423?

This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00085423 being conducted?

This trial has 1 study location across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial