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

Cancer Clinical Trial

Official title:

A Prospective Phase II Study of Radiation Therapy and Concurrent Cisplatin Chemotherapy in the Treatment of Locally Advanced or Metastatic Malignant Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00707161
• Other study ID #: HCI15461
• Status: Terminated
• Phase: Phase 2
• First received: June 26, 2008
• Last updated: October 28, 2014
• Start date: September 2005
• Est. completion date: February 2010

Study information

• Verified date: October 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Melanoma

Intervention

Radiation:
• Radiation Therapy
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).

Drug:
• Cisplatin
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.

Procedure:
• Surgical resection
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).

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	LDS Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate of Melanoma Lesions	Response rate of melanoma lesions was measured after treated with the trial agent.	2005-2010	No