CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
temozolomide +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01328535
NCT01328535Phase 2Completed

Individualized (Timed) Temozolomide Administration as a Means of Immune Reconstitution in Patients With Metastatic Melanoma

Mayo Clinic·interventional·Posted Apr 4, 2011·Updated Oct 22, 2020

In Brief

A Phase 2 clinical trial evaluating temozolomide, flow cytometry, and 3 other interventions for Recurrent Melanoma and Stage IV Melanoma. Completed, enrolled 25 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2011
Enrollment StartJan 1, 2011
Primary CompletionJun 22, 2013
Study CompletionJul 11, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.2 years ago

Interventions

temozolomidedrug

Given PO

flow cytometryother

Correlative studies

staining methodother

Correlative studies

biopsyprocedure

Optional correlative studies

laboratory biomarker analysisother

Correlative studies