Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma W… (NCT01100528) | Clinical Trial Compass
CompletedPhase 2
Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance
United States38 participantsStarted 2009-11-11
Plain-language 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.
Who can participate
SexALL
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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 \< 2
* Patients must be entered within 56 days of completing primary therapy
* White blood count (WBC) ≥ 3.0 x 10\^9/L
* Neutrophils ≥ 1.5 x 10\^9/L
* Platelets ≥ 100 x 10\^9/L
* international normalized ratio (INR) and partial thromboplastin time (PTT) \< 1.5 x upper limit of normal
* Hemoglobin ≥ 10 gm/100 ml
* Creatinine ≤ 2 mg/dl
* Bilirubin (total) ≤ 1.5 mg/dl
* Alanine transaminase (ALT) ≤ 1.5 x upper limit of normal
* Alkaline phosphatase ≤ 1.5 x upper limit of normal
* Aspartate aminotransferase (AST) ≤ 1.5 x upper limit of normal
* Patients must not have received any other system…
What they're measuring
1
Number of Patients With Disease-free Survival (DFS)