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


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer, Melanoma

Thank you

Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response Rate of Melanoma Lesions

Outcome Description:

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

Outcome Time Frame:

2005-2010

Safety Issue:

No

Principal Investigator

Dennis Shrieve, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huntsman Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

HCI15461

NCT ID:

NCT00707161

Start Date:

September 2005

Completion Date:

February 2010

Related Keywords:

  • Cancer
  • Melanoma
  • Melanoma

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112
LDS HospitalSalt Lake City, Utah  84143