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NCT00256282 · ClinicalTrials.gov registry record · Phase 2
Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma
A Phase 2 study of Metastatic Melanoma, sponsored by John P. Fruehauf.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT00256282: Completed Phase 2 study of Metastatic Melanoma, sponsored by John P. Fruehauf.
NCT00256282 is a Phase 2 study of Metastatic Melanoma that has completed, run by John P. Fruehauf. The registered enrollment target is 52 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00256282, a Phase 2 study of Metastatic Melanoma, has completed, sponsored by John P. Fruehauf.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who have metastatic melanoma which has advanced beyond the point at which local therapies such as surgery or radiation therapy would be helpful. Without effective treatment, metastatic melanoma is usually a severe and fatal disease. Chemotherapy agents or combinations of chemotherapy agents have produced tumor shrinkage in some patients, which has occasionally persisted. This research involves treatment with a combination of chemotherapy drugs known to be active against melanoma alone. The investigational purpose of this study is to determine if the combination of docetaxel, vinorelbine and sargramostim will produce a response (complete or partial) in metastasis melanoma. The researchers also wants to find out what side effects are associated with this combination of drugs.
Primary Outcome
The primary endpoint is to evaluate the six-month progression-free survival (PFS) in patients with AJCC stage IV metastatic melanoma treated with docetaxel and vinorelbine as first-line or post-first line (salvage) systemic therapy. Progressive disease is defined as any new lesion or a greater than or equal to 20% increase in the largest perpendicular diameter of the sum of the T-lesions identified on contrast enhanced CT or MRI scan.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Vinorelbine
- DRUG Sargramostim
Study Locations (1)
California
- Chao Family Comprehensive Cancer Center - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2003-04 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT00256282 record still lists
NCT00256282 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Metastatic Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.
NCT00256282 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00256282 about?
NCT00256282 is a clinical study titled "Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma". This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who have metastatic melanoma which has advanced beyond the point at which local therapies such as surgery or radiation therapy would be helpful. Without effective treatment, metastatic melanoma is usually a seve...
What is the current status of trial NCT00256282?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2003-04. Estimated completion is 2012-08.
What conditions does trial NCT00256282 study?
This clinical trial studies the following conditions: Metastatic Melanoma.
What interventions are being tested in trial NCT00256282?
The interventions under investigation include: Docetaxel (DRUG), Vinorelbine (DRUG), Sargramostim (DRUG).
Who is sponsoring clinical trial NCT00256282?
This trial is sponsored by John P. Fruehauf, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00256282 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00256282's enrollment target sits among peer trials
52 33rd of 91 higher than 57 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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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