Radiation Therapy and Concurrent Cisplatin Chemotherapy for Locally Advanced or Metastatic Malignant Melanoma
Condition: Cancer; Melanoma
MeSH terms: Melanoma
Intervention: Radiation Therapy; Cisplatin; Surgical resection
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).; 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).
Intervention MeSH terms: Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.