Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma. (SBRT/IL-2)
|ClinicalTrials.gov Identifier: NCT01416831|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2011
Last Update Posted : January 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Other: Radiation therapy and high-dose IL-2 Drug: High-dose IL-2||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Active Comparator: High-dose IL-2
Patients receive standard high-dose IL-2 therapy, with an opportunity to crossover to the experimental arm if there is disease progression noted after two cycles of high-dose IL-2.
Drug: High-dose IL-2
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.
Experimental: Radiation therapy and high-dose IL-2
Patients 1-20 who are assigned to receive radiation therapy will receive a single dose of radiation before IL-2; patients 21-44 assigned to receive radiation will receive two doses of radiation before receiving high-dose IL-2.
Other: Radiation therapy and high-dose IL-2
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.
- Change in diameter of target lesions [ 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) ]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.
- Response rate in crossover patients [ Time Frame: 7 weeks following IL-2 course that was preceded by radiation ]Measure the response rate of patients with metastatic melanoma who receive radiation and high-dose IL-2 who had disease progression after high-dose IL-2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416831
|United States, Oregon|
|Providence Cancer Center|
|Portland, Oregon, United States, 97213|
|Principal Investigator:||Brendan Curti, M.D.||Providence Health & Services|
|Principal Investigator:||Steven K. Seung, M.D.||Providence Health & Services|
|Principal Investigator:||Marka Crittenden, MD, PhD||Providence Health & Services|