Phase 2
Completed N=25
Individualized Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
Recurrent Melanoma · Stage IV Melanoma
Source: ClinicalTrials.gov NCT01328535 ↗
Enrolled (actual)
25
Serious AEs
12.5%
Results posted
Nov 2018
Primary outcomePrimary: Progression-Free Survival at 4 Months — 22.2 percentage of patients
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
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 | — |
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
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. Informational only — not medical advice.