Radiation Therapy and Concurrent Cisplatin Chemotherapy for Locally Advanced or Metastatic Malignant Melanoma

Phase 2

Terminated

• Conditions: Cancer; Melanoma
• Interventions: Radiation: Radiation Therapy; Drug: Cisplatin; Procedure: Surgical resection

• Registration Number: NCT00707161
• Lead Sponsor: University of Utah

Brief Summary

The study is a prospective phase II trial of radiation therapy concurrent with cisplatin chemotherapy in the treatment of locally advanced or metastatic melanoma in patients who are deemed to require radiation therapy by treating physicians for purposes of local control or palliation. Eligibility criteria include pathologically confirmed melanoma. Patients will undergo radiation therapy (20 treatments of 2.5 Gy for a total of 50 Gy) concurrent with cisplatin chemotherapy.

Detailed Description

This is a phase II, prospective trial designed to determine the response rate achieved with cisplatin delivered concurrent with radiation therapy in locally advanced or metastatic melanoma.

Radiation therapy will be delivered concurrent with cisplatin chemotherapy as outlined in table 2. Radiation therapy dose will be 50 Gy (2.5 Gy per day, 5 days per week, for 20 treatments). Cisplatin dose will be 100 mg/m2 given i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.

Surgical resection of residual (or recurrent) melanoma for cure or for palliation may be performed following chemoradiation if deemed appropriate by the treating physicians (surgical resection may be planned following pre-operative chemoradiation or may be performed for salvage due to inadequate response to chemoradiation or for relapse following chemoradiation). Surgical resection will not be performed until at least 4 weeks following chemoradiation (unless deemed emergent by the treating physicians).

If the patient's tumor has inadequate response to chemoradiation then salvage therapies can be used as deemed appropriate by the treating physicians. In order to allow adequate response to radiation therapy, salvage therapies will not be utilized until at least 4 weeks following chemoradiation unless deemed emergent by the treating physicians.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-06-30
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2011-04-20
• Results First Submitted QC: 2012-03-06
• Results First Posted: 2012-04-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	Surgical resection	-
All participants	Radiation Therapy	-
All participants	Cisplatin	-

Primary Outcome Measures

Name	Time	Method
Response Rate of Melanoma Lesions	2005-2010	Response rate of melanoma lesions was measured after treated with the trial agent.

Trial Locations

Locations (2)

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

LDS Hospital; 🇺🇸 Salt Lake City, Utah, United States