Phase 2 N=25 Treatment

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

Recurrent Melanoma · Stage IV Melanoma

Bottom Line

View on ClinicalTrials.gov: NCT01328535 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Nov 2018

Primary outcome: Primary: Progression-Free Survival at 4 Months — 22.2 percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: temozolomide (Drug); flow cytometry (Other); staining method (Other); biopsy (Procedure); laboratory biomarker analysis (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-Free Survival at 4 Months	22.2	—
SECONDARY Progression-Free Survival	3.4; 7.2	—
SECONDARY Overall Survival	23.1; 17.5	—
SECONDARY Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)	4.2; 8.3; 8.3; 25; 4.2; 4.2	—

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

Eligibility Criteria

Inclusion Criteria

Histologic/cytologic proof of stage IV malignant melanoma not amenable to surgery
Any number of previous chemotherapy regimens (except those containing TMZ or dacarbazine [DTIC]) in the metastatic setting are allowed as long as >= 4 weeks have elapsed from last treatment
Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as >= 1.0 cm with spiral CT scan, or ≥ 2 cm with computed tomography (CT) component of a positron emission tomography (PET)/CT; Note: disease that is measurable by physical examination only is not eligible
Life expectancy of >= 3 months
Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2
Recovered from side effects that might interfere with the protocol therapy and: - >= 4 weeks must have elapsed from last radiation treatment to time of study entry - >= 4 weeks must have elapsed from the last chemotherapy administration to time of study entry
Absolute neutrophil count (ANC) >= 1500/mL
Platelet count >= 100,000/mcl
Hemoglobin >= 9gm/mcl
Creatinine = = 3 months and the patient is off steroids for >= 4 weeks

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01328535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.