Phase 2
N=10
Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma
Malignant Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00715793 ↗Enrolled (actual)
10
Serious AEs
18.0%
Results posted
Oct 2017
Primary outcome: Primary: Percentage of Participants That Experienced a Dose Limiting Toxicity (DLT) — 0; 17 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Decitabine (Drug); Temozolomide (Drug); biopsy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hussein Tawbi
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants That Experienced a Dose Limiting Toxicity (DLT) |
0; 17 | — |
| PRIMARY Overall Response Rate (ORR) |
18 | — |
| PRIMARY Recommended Phase 2 Dose (RP2D) of DAC + TMZ |
0.15 | — |
| SECONDARY Disease Control Rate (DCR) |
61 | — |
| SECONDARY Progression-free Survival (PFS) |
3.4 | — |
| SECONDARY 6-month Progression-free Survival (PFS) Rate |
32.4 | — |
| SECONDARY Overall Survival (OS) |
12.4 | — |
| SECONDARY 1-year Overall Survival (OS) Rate |
56 | — |
Summary
The combination of TMZ and DAC may effect dual modulation of DNA repair genes resulting in improved clinical response.
Eligibility Criteria
Inclusion Criteria
- Patients who have non-resectable Stage IIIB or stage IV metastatic melanoma that have progressed despite prior therapies.
- Life expectancy of at least 12 weeks.
- ECOG performance status of 0, 1 and 2.
- ≥18 years of age.
- Patients who have not received any other chemotherapeutic, biological or investigational agent within 28 days of study drug administration.
- First line and active brain metastases (metastatic lesions to the brain that have been adequately treated with surgery and/or appropriate radiation therapy and that have documented stability for >4 weeks or >2 weeks if treated with stereotactic radiosurgery, remain eligible)
Exclusion Criteria
- Any evidence of renal dysfunction (proteinuria, estimated creatinine clearance from serum creatinine test of 2.0 except in patients with Gilbert's syndrome).
- Prior treatment with alkylating agents (including TMZ and DTIC).
- Active brain metastases (metastatic lesions to the brain that have been adequately treated with surgery and/or appropriate radiation therapy and that have documented stability for >4 weeks remain eligible).
- Active infections or serious general medical conditions.
- Female patients of child-bearing age who are not on adequate contraception, or are pregnant or breast-feeding.
Data sourced from ClinicalTrials.gov (NCT00715793). 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.