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

Primary Purpose

Cancer, Melanoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Cisplatin
Surgical resection
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Signed study-specific consent form prior to registration.
  • Pathologically confirmed malignant melanoma.
  • Measurable melanoma lesion deemed to require radiation by treating physicians for purposes of local control or palliation. The lesion may be the primary melanoma, a nodal metastasis, or a distant metastasis. Recurrent lesions are allowed.
  • Lesion has to be measurable clinically or radiographically in 2 dimensions.
  • Karnofsky Performance Scale (KPS) > 70.

  • Laboratory values

    • White blood cells (WBC) > 3000/mm3
    • Absolute granulocyte count > 1,500
    • Platelets > 100,000/mm3
    • Total bilirubin < 2.0 x institutional upper limit of normal
    • AST or ALT (aminotransferase/alanine aminotransferase) < 2.5 x institutional upper limit of normal
    • Serum calcium < 1.3 x institutional upper limit of normal
    • Serum creatinine < 1.5 mg/dL or Creatinine clearance > 50 cc/min,calculated as follows: CCr = 0.85 x (140-age) x (weight in kg) 72 x serum creatinine in mg/dL

Exclusion criteria:

  • Systemic therapy for malignant melanoma within one month preceding trial enrollment.
  • Prior irradiation to the planned field.
  • Concomitant chemotherapy (in addition to cisplatin) or biologic therapy is allowed.
  • Significant infection or other co-existent medical condition which would prevent the use of full dose chemotherapy.
  • Pre-existing sensory neuropathy (CTC 3.0 ≥ Grade II)
  • Pregnancy or lactation.

Sites / Locations

  • Huntsman Cancer Institute
  • LDS Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All participants

Arm Description

Outcomes

Primary Outcome Measures

Response Rate of Melanoma Lesions
Response rate of melanoma lesions was measured after treated with the trial agent.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2008
Last Updated
March 1, 2017
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT00707161
Brief Title
Radiation Therapy and Concurrent Cisplatin Chemotherapy for Locally Advanced or Metastatic Malignant Melanoma
Official Title
A Prospective Phase II Study of Radiation Therapy and Concurrent Cisplatin Chemotherapy in the Treatment of Locally Advanced or Metastatic Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
discontinued due to low enrollment
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All participants
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
chemotherapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical resection
Other Intervention Name(s)
surgery
Intervention Description
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).
Primary Outcome Measure Information:
Title
Response Rate of Melanoma Lesions
Description
Response rate of melanoma lesions was measured after treated with the trial agent.
Time Frame
2005-2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Signed study-specific consent form prior to registration. Pathologically confirmed malignant melanoma. Measurable melanoma lesion deemed to require radiation by treating physicians for purposes of local control or palliation. The lesion may be the primary melanoma, a nodal metastasis, or a distant metastasis. Recurrent lesions are allowed. Lesion has to be measurable clinically or radiographically in 2 dimensions. Karnofsky Performance Scale (KPS) > 70. Laboratory values White blood cells (WBC) > 3000/mm3 Absolute granulocyte count > 1,500 Platelets > 100,000/mm3 Total bilirubin < 2.0 x institutional upper limit of normal AST or ALT (aminotransferase/alanine aminotransferase) < 2.5 x institutional upper limit of normal Serum calcium < 1.3 x institutional upper limit of normal Serum creatinine < 1.5 mg/dL or Creatinine clearance > 50 cc/min,calculated as follows: CCr = 0.85 x (140-age) x (weight in kg) 72 x serum creatinine in mg/dL Exclusion criteria: Systemic therapy for malignant melanoma within one month preceding trial enrollment. Prior irradiation to the planned field. Concomitant chemotherapy (in addition to cisplatin) or biologic therapy is allowed. Significant infection or other co-existent medical condition which would prevent the use of full dose chemotherapy. Pre-existing sensory neuropathy (CTC 3.0 ≥ Grade II) Pregnancy or lactation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Shrieve, MD
Organizational Affiliation
Huntsman Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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