HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03435302
• Other study ID #: BCHMMAT001
• Status: Recruiting
• Phase: Phase 3
• First received: February 8, 2014
• Last updated: February 9, 2018
• Start date: February 2014
• Est. completion date: February 2019

Study information

• Verified date: February 2018
• Source: Beijing Cancer Hospital
• Contact: Bin Lian, MD
• Phone: +86(10)88196951
• Email: lianbin0214[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: February 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

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.
• High-Dose IFN-a2b
Interferon belongs to the large class of glycoproteins known as cytokines.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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