HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

NCT03435302 | Unknown Phase 3 DMC

• 1 other identifier: BCHMMAT001
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma

Keywords

Mucosal Melanoma,Adjuvant Therapy,IFN-a2b,Temozolomide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Temozolomide Plus Cisplatin

EXPERIMENTAL

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

High-Dose IFN-a2b

ACTIVE COMPARATOR

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

Interventions

Temozolomide Plus Cisplatin DRUG

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.

Also known as: Temodal., cisplatinum

Temozolomide Plus Cisplatin

High-Dose IFN-a2b DRUG

Interferon belongs to the large class of glycoproteins known as cytokines.

Also known as: Intron

High-Dose IFN-a2b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 18 years;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Pathologically confirmed diagnosis of mucosal melanoma;
• Completely resected primary tumor (once regional lymph nodes were involved, diagnosed by clinical or imaging examinations, lymphadenectomy was conducted);
• No prior systemic adjuvant therapy or regional radiotherapy;
• 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);
• Normal bone marrow function; and adequate liver and renal function \[including white blood cell (WBC) count \> 3,000/mm\^3;absolute neutrophil count \> 1,500/mm\^3; platelets \>100,000/mm\^3; serum creatinine less than two times of the upper limit of normal (ULN); bilirubin less than 1.5 times of ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times of ULN; international normalized ratio less than 1.5 times of ULN; and partial thromboplastin time less than ULN\].

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Temozolomide; Cisplatin; Introns

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Jun Guo, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Lian, MD

CONTACT

+86(10)88196951; lianbin0214@126.com

Lu Si, MD

CONTACT

+86(10)88196951; silu.net@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 8, 2014
• First Posted: February 19, 2018
• Study Start: February 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2019
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

CN (1)