Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma.
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Intervention: Radiation therapy and high-dose IL-2; High-dose IL-2
Intervention description: Patients 1 - 20 will receive a single fraction of radiation. Patients 21 through the completion of the study will receive two fractions. The dose for all patients will be 20 Gy per fraction to the prescription line at the edge of the planning treatment volume (PTV) with the last dose delivered on a Friday before IL-2 administration. For patients receiving two radiation doses, the doses can be administered on the Wednesday and Friday before IL-2 starts. Patients who are assigned to IL-2 monotherapy and have progressive disease after two IL-2 cycles are then eligible to receive SBRT before cycle 3 of IL-2 commences, single fraction for patients 1-20 and two fractions for patients 21- end of study.; IL-2 will be given on a Monday at a dose of 600,000 IU per kilogram IV every 8 hours for up to 14 doses each cycle. The second cycle is planned 16 days after cycle 1 but may be delayed up to one week to allow toxicity to resolve. The maximum number of doses that can be given during two cycles will be 28 doses. Patients who respond after two cycles can receive 4 more cycles of IL-2. Patients with disease progression after 2 cycles may elect to receive radiation before a 3rd cycle of IL-2. If patients crossover, IL-2 will be given on the Monday following the last dose of radiation, at a dose of 600,000 IU per kilogram IV every 8 hours for a maximum of 14 doses each cycle. Another cycle is planned 16 days after cycle 3 but may be delayed up to one week to allow toxicity to resolve.
Intervention MeSH terms: Interleukin-2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic melanoma; IL-2; Interleukin 2; Radiation; Stereotactic Body Radiation Treatment; SBRT; Immunotherapy

Summary:

      The purpose of this study is compare the response rates in patients with metastatic melanoma
      treated with high-dose IL-2 to patients treated with high-dose IL-2 along with radiation
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmation of melanoma will be required by previous biopsy or cytology.

          -  Patients must be ≥ 18 years of age.

          -  Patients must have tumors amenable to SBRT in lungs, mediastinum, chest wall, bones
             (other than long bones), or liver (inclusive of immediately adjacent masses), 1 - 3
             foci; no minimum size, but none greater than 7 cm. Patients may have other metastases
             but only a maximum of 3 will be treated.

          -  ECOG performance status of 0-1.

          -  Women of childbearing potential must have a serum or urine pregnancy test performed
             within 72 hours prior to the start of protocol treatment. The results of this test
             must be negative in order for the patient to be eligible. In addition, women of
             childbearing potential as well as male patients must agree to take appropriate
             precautions to avoid pregnancy.

          -  Patients must sign a study-specific consent form.

        Exclusion Criteria:

          -  No metastatic site amenable to SBRT.

          -  Patients with brain metastases not candidates for radiosurgery.

          -  Previous radiation to sites proposed for radiation as part of this study.

          -  Patients with active systemic, pulmonary, or pericardial infection.

          -  Pregnant or lactating women.

          -  Evidence of ischemia on exercise tolerance test, stress thallium study, or baseline
             EKG.

          -  DLCO, FEV1 or FEV1/FVC less than 70% of predicted due to clinically significant
             underlying pulmonary disease. For any pulmonary function test values less than
             predicted values, the PI will review, and document the patient's suitability for high
             dose IL-2 therapy.

          -  WBC < 3.0 x 109/L

          -  Hgb < 9.0 g/dL

          -  AST/ALT > 3 times the upper limit of the normal range

          -  total bilirubin > 1.9 g/dL

          -  creatinine > 1.9 g/dL

          -  Patient requires chronic steroids.