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NCT01328535 · ClinicalTrials.gov registry record · Phase 2

Individualized Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

A Phase 2 study of Recurrent Melanoma and Stage IV Melanoma, sponsored by Mayo Clinic.

Completed
Registry status
Phase 2
Development phase
25
Enrollment target
1
Study location

NCT01328535: Completed Phase 2 study of Recurrent Melanoma and Stage IV Melanoma, sponsored by Mayo Clinic.

NCT01328535 is a Phase 2 study of Recurrent Melanoma and Stage IV Melanoma that has completed, run by Mayo Clinic. The registered enrollment target is 25 participants, below the 172-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01328535, a Phase 2 study of Recurrent Melanoma and Stage IV Melanoma, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 2
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

This clinical trial studies individualized temozolomide (TMZ) in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as TMZ, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving TMZ at different times, which are determined individually for each patient based on the phase (biorhythm) of the immune system response against the tumor may allow for a better drug response and may kill more tumor cells

Primary Outcome

The distribution of time to progression will be estimated using the method of Kaplan-Meier and the 4 month progression-free rate (percentage) will be provided. Progression is defined as: At least one of the following must be true: At least one new malignant lesion, which also includes any lymph node that was normal at baseline (\< 1.0 cm short axis) and increased to ≥ 1.0 cm short axis during follow-up. At least a 20% increase in PBSD (sum of the longest diameter for all target lesions plus the

Conditions Studied

Recurrent Melanoma Stage IV Melanoma

Interventions

  • OTHER laboratory biomarker analysis
  • PROCEDURE biopsy
  • DRUG temozolomide
  • OTHER flow cytometry
  • OTHER staining method

Study Locations (1)

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2011-01
Est. Completion 2018-07-11
Phase Phase 2
Mayo Clinic

2,844 total trials

What the finished NCT01328535 record still lists

NCT01328535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 172-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (85% lower).

The record links to 2 conditions, with Recurrent Melanoma appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.

NCT01328535 reports a single indexed study location in Minnesota.

Frequently Asked Questions

What is clinical trial NCT01328535 about?

NCT01328535 is a clinical study titled "Individualized Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery". This clinical trial studies individualized temozolomide (TMZ) in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as TMZ, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividin...

What is the current status of trial NCT01328535?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2011-01. Estimated completion is 2018-07-11.

What conditions does trial NCT01328535 study?

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

What interventions are being tested in trial NCT01328535?

The interventions under investigation include: laboratory biomarker analysis (OTHER), biopsy (PROCEDURE), temozolomide (DRUG), flow cytometry (OTHER), staining method (OTHER).

Who is sponsoring clinical trial NCT01328535?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01328535 being conducted?

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

Learn More About Clinical Trials

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 NCT01328535's enrollment target sits among peer trials

25 18th of 23 higher than 5 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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Related registry views

Source: ClinicalTrials.gov NCT01328535, the US trial registry maintained by the National Library of Medicine. NCT01328535 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.