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

• Status: Terminated
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Cisplatin

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.