Phase II Randomized Study of High Dose Interleukin-2 Versus Stereotactic Body Radiation (SBRT) and High Dose Interleukin-2 (IL-2) in Patients With Metastatic Melanoma
18 Years
N/A
Both
Metastatic Melanoma
Trial Information
Phase II Randomized Study of High Dose Interleukin-2 Versus Stereotactic Body Radiation (SBRT) and High Dose Interleukin-2 (IL-2) in Patients With Metastatic Melanoma
All patients will receive high-dose IL-2. Half the patients enrolled will be randomly
selected to receive radiation therapy to up to three tumors prior to receiving high-dose
IL-2. Among the first 20 patients enrolled, those assigned to receive radiation will
receive a single dose of radiation and for patients 21-44, those assigned to receive
radiation will receive 2 doses of radiation.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change in diameter of target lesions
Outcome Description:
All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs, will be identified as target lesions and recorded and measured at baseline. Target lesions will be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the baseline, which will be used as reference by which to characterize the objective tumor response.
Outcome Time Frame:
Within 28 days of starting treatment, after one course of IL-2 (7 weeks), and after each subsequent course of IL-2 (Weeks 14 and 21)
Safety Issue:
No
Principal Investigator
Brendan Curti, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Providence Health & Services
Authority:
United States: Institutional Review Board
Study ID:
11-062A
NCT ID:
NCT01416831
Start Date:
July 2011
Completion Date:
June 2015
Related Keywords:
- Metastatic Melanoma
- metastatic melanoma
- IL-2
- Interleukin 2
- Radiation
- Stereotactic Body Radiation Treatment
- SBRT
- Melanoma
Name | Location |
|---|---|
| Providence Cancer Center | Portland, Oregon 97213-2933 |
