HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

• ClinicalTrials.gov Identifier: NCT03435302
• Recruitment Status: Unknown
• First Posted: February 19, 2018
• Last Update Posted: February 19, 2018
• Sponsor: Beijing Cancer Hospital
• Information provided by (Responsible Party): Lu Si, Beijing Cancer Hospital

Tracking Information

• First Submitted Date: February 8, 2014
• First Posted Date: February 19, 2018
• Last Update Posted Date: February 19, 2018
• Study Start Date: February 2014
• Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 9, 2018): Relapse-free survival (RFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma. [ Time Frame: Participants will be followed for an expected average of 24 months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 9, 2018)

• Distant metastasis-free survival(DMFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma
• 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
• 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.
• 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
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.

  Other Names:

  • Temodal.
  • cisplatinum
• Drug: High-Dose IFN-a2b
  Interferon belongs to the large class of glycoproteins known as cytokines.
  Other Name: Intron

Study Arms

• 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
  Intervention: Drug: Temozolomide Plus Cisplatin
• 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.
  Intervention: Drug: High-Dose IFN-a2b

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 9, 2018): 204
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2019
• Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03435302
• Other Study ID Numbers: BCHMMAT001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Lu Si, Beijing Cancer Hospital
• Study Sponsor: Beijing Cancer Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jun Guo, MD; Beijing Cancer Hospital

• PRS Account: Beijing Cancer Hospital
• Verification Date: February 2018