HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

A Multicenter, Randomized, Controlled, Phase III Trial Comparing High-Dose IFN-a2b With Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

This is a a multicenter, randomized, controlled, phase III trial comparing High-Dose IFN-a2b with Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma.The study objective is to compare efficacy and safety of High-dose IFN-a2b and temozolomide-based chemotherapy as adjuvant therapy.

Study Overview

• Status: Unknown
• Conditions: Melanoma
• Intervention / Treatment: Drug: Temozolomide Plus Cisplatin; Drug: High-Dose IFN-a2b

Detailed Description

The patients who comply with the inclusion and exclusion criteria will be enrolled. The estimated recruiting duration is 36 months. Patients with resected mucosal melanoma were randomized into two groups: HDI group (group A, treated with i.v. 15×10^6U/m^2/d IFN-a2b on days 1 to 5 each week for 4 weeks, followed by s.c. 9×10^6U IFN-a2b three times per week for 48 weeks), and chemotherapy group (group B, per os 200 mg/m^2/d temozolomide on days 1 to 5 plus i.v. 75 mg/m^2 cisplatin divided into 3 days,which was repeated every 3 weeks for six cycles). All patients will be followed for at least 2 years.

• Study Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100142
    • Recruiting
    • Beijing Cancer Hospital
    • Contact: Lu Si, MD; Phone Number: +86(10)88196951; Email: silu.net@hotmail.com
    • Contact: Bin Lian, MD; Phone Number: +86(10)88196951; Email: lianbin0214@126.com
    • Sub-Investigator: Bin Lian, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age more than 18 years;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
3. Pathologically confirmed diagnosis of mucosal melanoma;
4. Completely resected primary tumor (once regional lymph nodes were involved, diagnosed by clinical or imaging examinations, lymphadenectomy was conducted);
5. No prior systemic adjuvant therapy or regional radiotherapy;
6. No evidence of distant metastatic disease evaluated by means of lymph nodes ultrasound, endoscopy, and ultrasound of anorectum and genitourinary tract, single-photon emission computed tomography (CT) of bone, and whole-body spiral CT or positron emission tomography-CT (PET-CT);
7. Normal bone marrow function; and adequate liver and renal function [including white blood cell (WBC) count > 3,000/mm^3;absolute neutrophil count > 1,500/mm^3; platelets >100,000/mm^3; serum creatinine less than two times of the upper limit of normal (ULN); bilirubin less than 1.5 times of ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times of ULN; international normalized ratio less than 1.5 times of ULN; and partial thromboplastin time less than ULN].

Exclusion Criteria:

1. Cutaneous melanoma or ocular melanoma or melanoma of unknown primary site;
2. Incomplete resection or primary tumor unable to be resected;
3. A second cancer diagnosis;
4. Definite medical history of cirrhoses of the liver or autoimmune diseases;
5. Severe depression; and pregnant or lactating female.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Temozolomide Plus Cisplatin; per os 200 mg/m^2/d temozolomide on days 1 to 5 plus i.v. 75 mg/m^2 cisplatin divided into 3 days,which was repeated every 3 weeks for six cycles	Drug: Temozolomide Plus Cisplatin; Temozolomide is the oral analog of dacarbazine (DTIC), shows potential advantages over dacarbazine. Cisplatin is an agent that can potentially enhance the activity of temozolomide.; Other Names: cisplatinum; Temodal.
Active Comparator: High-Dose IFN-a2b; Participants will be treated with i.v. 15×10^6U/m^2/d IFN-a2b on days 1 to 5 each week for 4 weeks, followed by s.c. 9×10^6U IFN- a2b three times per week for 48 weeks.	Drug: High-Dose IFN-a2b; Interferon belongs to the large class of glycoproteins known as cytokines.; Other Names: Intron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relapse-free survival (RFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.	Participants will be followed for an expected average of 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Distant metastasis-free survival(DMFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.	Participants will be followed for an expected average of 24 months
Overall survival (OS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.	From date of randomization until the date of death from any cause, assessed up to 48 months
Number of Participants with Adverse Events of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma	Participants will be followed for the duration of hospital stay, an expected average of 12 months

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: February 8, 2014
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Mucosal Melanoma,Adjuvant Therapy,IFN-a2b,Temozolomide
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Cisplatin; Temozolomide
• Other Study ID Numbers: BCHMMAT001