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NCT00397982 · ClinicalTrials.gov registry record · Phase 2

Temsirolimus and Bevacizumab in Treating Patients With Stage III or Stage IV Malignant Melanoma

A Phase 2 study of Recurrent Melanoma and Stage IV Skin Melanoma, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
17
Enrollment target
2
Study locations

NCT00397982: Completed Phase 2 study of Recurrent Melanoma and Stage IV Skin Melanoma, sponsored by National Cancer Institute (NCI).

NCT00397982 is a Phase 2 study of Recurrent Melanoma and Stage IV Skin Melanoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants, below the 172-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00397982, a Phase 2 study of Recurrent Melanoma and Stage IV Skin Melanoma, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
17 participants
Enrollment target
2
Study locations

Study Summary

This phase II trial is studying how well giving temsirolimus together with bevacizumab works in treating patients with stage III or stage IV malignant melanoma. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of malignant melanoma by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may kill more tumor cells.

Primary Outcome

Evaluated using Response Evaluation Criteria In Solid Tumor (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter

Interventions

  • OTHER Laboratory Biomarker Analysis
  • PROCEDURE Therapeutic Conventional Surgery
  • BIOLOGICAL Bevacizumab
  • DRUG Temsirolimus

Study Locations (2)

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia

Virginia

  • University of Virginia Cancer Center - Charlottesville

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2008-01
Est. Completion 2013-07
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00397982 record still lists

NCT00397982 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 172-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (90% lower).

The record links to 4 conditions, with Recurrent Melanoma appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT00397982 reports a single indexed study location in Pennsylvania, Virginia.

Frequently Asked Questions

What is clinical trial NCT00397982 about?

NCT00397982 is a clinical study titled "Temsirolimus and Bevacizumab in Treating Patients With Stage III or Stage IV Malignant Melanoma". This phase II trial is studying how well giving temsirolimus together with bevacizumab works in treating patients with stage III or stage IV malignant melanoma. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Monoclonal antibodies, such as bev...

What is the current status of trial NCT00397982?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2008-01. Estimated completion is 2013-07.

What conditions does trial NCT00397982 study?

This clinical trial studies the following conditions: Recurrent Melanoma, Stage IV Skin Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma.

What interventions are being tested in trial NCT00397982?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Therapeutic Conventional Surgery (PROCEDURE), Bevacizumab (BIOLOGICAL), Temsirolimus (DRUG).

Who is sponsoring clinical trial NCT00397982?

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

Where is trial NCT00397982 being conducted?

This trial has 2 study locations across Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Recurrent 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 NCT00397982's enrollment target sits among peer trials

17 23rd of 23 higher than 1 of 23 other Recurrent Melanoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent 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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Source: ClinicalTrials.gov NCT00397982, the US trial registry maintained by the National Library of Medicine. NCT00397982 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.