Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma. (SBRT/IL-2)
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|ClinicalTrials.gov Identifier: NCT01416831|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2011
Results First Posted : November 15, 2022
Last Update Posted : March 27, 2023
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|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 :||44 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|
|Actual Study Start Date :||July 1, 2011|
|Actual Primary Completion Date :||April 5, 2017|
|Estimated Study Completion Date :||December 2023|
Active Comparator: Arm A: IL-2 Monotherapy
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. Crossover patients will be included in Arm A.
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: Arm B: SBRT + IL-2
Patients 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.
- Best Overall Tumor Response of High Dose IL-2 vs. SBRT + High Dose IL-2 [ Time Frame: At the end of Cycle 2 (Week 14). ]
Determine the best overall tumor response rate of high dose IL-2 versus SBRT + high-dose IL-2 using RECIST v1.1 assessed by CT/MRI, criteria applied to all target and non-target lesions with the exclusion of sites treated with SBRT. For patients who have SBRT after progression on IL-2 monotherapy, the response rate will be recorded, but not counted as a response for the primary objective.
Overall response rate (ORR) includes all measurable and non-measurable target lesions except the lesions treated by SBRT, which were assessed separately. Both CT and positron emission tomography imaging were employed to assess response.
Complete Response: disappearance of all target/non-target lesions and no abnormalities on PET; Partial Response: ≥30% decrease in sum of longest diameter (LD) of target lesions; Progressive Disease: ≥20% increase in sum of LD recorded since tx start or appearance of ≥1 new lesions; Stable Disease: Neither qualifying for PR nor PD since tx started.
- Response Rate in Crossover Patients [ Time Frame: 7 weeks following Cycle 2 (Week 21). ]Measure the response rate of patients who have disease progression after the first IL-2 cycles (using RECIST criteria) who received SBRT prior to cycle 3 of IL-2.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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|
Documents provided by Providence Health & Services:
|Responsible Party:||Providence Health & Services|
|Other Study ID Numbers:||
|First Posted:||August 15, 2011 Key Record Dates|
|Results First Posted:||November 15, 2022|
|Last Update Posted:||March 27, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Stereotactic Body Radiation Treatment
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs