Phase 2
N=38
Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance
Ciliary Body and Choroid Melanoma, Medium/Large Size · Ciliary Body and Choroid Melanoma, Small Size · Iris Melanoma · Recurrent Intraocular Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01100528 ↗Enrolled (actual)
38
Serious AEs
5.3%
Results posted
Oct 2018
Primary outcome: Primary: Number of Patients With Disease-free Survival (DFS) — 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- recombinant interferon alfa-2b (Biological); dacarbazine (Drug); laboratory biomarker analysis (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Disease-free Survival (DFS) |
8 | — |
| SECONDARY Number of Participants With Toxicity or Grade 4 Adverse Events Via CTCAE Version 3.0 |
2 | — |
| SECONDARY Changes in Plasma Biomarkers and Their Association With DFS |
— | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. Giving interferon alfa-2b together with dacarbazine may be an effective treatment for primary uveal melanoma.
PURPOSE: This phase II trial is studying how well giving dacarbazine together with recombinant interferon alfa-2b works in treating patients with primary uveal melanoma with genetic imbalance.
Eligibility Criteria
Inclusion
- Patients must have a diagnosis, either cytologic or histologic, of melanoma of the iris, ciliary body and/or choroid
- Patient's tumor must exhibit monosomy 3 and/or 8q amplification as determined by karyotype, comparative genomic hybridization (CGH), polymerase chain reaction (PCR)-based microsatellite, and/or Fluorescence in situ Hybridization (FISH) analysis; tissue or cells for analysis can be obtained at enucleation, resection, or by fine needle aspirate (FNA).
- Patients must have undergone adequate primary therapy; this can include enucleation, brachytherapy, proton beam radiotherapy, stereotactic irradiation, trans-scleral local resection, transretinal resection or diode laser thermotherapy
- Patients must have had chest X-ray and hepatic ultrasound or other imaging methods such as CT or MRI to eliminate distant disease
- Patients must have a performance status (ECOG) of 3 years
- Patients with organ allografts
Data sourced from ClinicalTrials.gov (NCT01100528). 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.