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Radiotherapy as an Immunological Booster in Patients With Metastatic Melanoma or Renal Cell Carcinoma Treated With High-dose Interleukin-2 (IL2HD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01884961
Recruitment Status : Recruiting
First Posted : June 24, 2013
Last Update Posted : February 26, 2021
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Brief Summary:

Title: Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response

Phase: Proof of Principle phase II study

Study Design: Single center, open-label trial to assess the immune response and potential biomarkers predictive of response

Study Duration:

Total duration: 36 months Enrollment: 20 months Treatment: 5 months per patient Follow-up every three months

Number of Subjects:

Mini-max two-stage Simon design:

• Step 1: 7 patients enrolled

If tumor antigen-specific immune response is observed in at least 3 patients:

• Step 2: recruitment of an additional 12 patients

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Cancer Malignant Melanoma, Metastatic Other: Boost of radiotherapy + high dose IL-2 treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiotherapy as an Immunological Booster in Patients With Metastatic Melanoma or Renal Cell Carcinoma Treated With High-dose Interleukin-2: Evaluation of Biomarkers of Immunologic and Therapeutic Response
Actual Study Start Date : July 9, 2012
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: arm A

Boost of radiotherapy + high dose IL-2 treatment: Three daily doses boost radiotherapy at 6-12 Gy to at least 1, and up to a maximum of 5, metastatic fields, will be administrated on days -4 -3 -2 or -3 -2 -1 before the first and the third cycle of IL-2 (Interleukin 2). The first day of administration of IL-2 of each cycle is the day +1.

Treatment with IL-2 (dose 18 MIU/m2/day in 500cc by continuous IV (intravenous) infusion for 72 hours) will start on day +1 and will be administered every 3 weeks up to 4 cycles, than every 3-4 weeks for a further 2 cycles.

Patients will be evaluated every 8 weeks with computed tomography to determine the response, and every 3 months after completion of treatment until death.

Other: Boost of radiotherapy + high dose IL-2 treatment
Boost of radiotherapy + high dose IL-2 treatment

Primary Outcome Measures :
  1. immunological efficacy [ Time Frame: 3 years ]
    Determination of the immunological efficacy of the combined RT (radiotherapy)/HDIL-2 (high dose Interleukin 2) treatment in terms of ability of the treatment to enhance the proportion of circulating immune effectors specific for tumor antigens known to be expressed in RCC (Renal Cell Carcinoma) and/or melanoma

  2. Biomarkers predictive value for treatment benefit [ Time Frame: 3 years ]
    Determination of the predictive value of pretreatment biomarkers in identifying patients who will benefit from combined RT/HDIL-2 treatment

Secondary Outcome Measures :
  1. Toxicity from the time of their first treatment with HD 2. [ Time Frame: 3 years ]
    Evaluation of safety and tollerability of the experimental treatment. The percentage of patients reporting an Adverse Event (AE) up to 30 days after HD-IL-2 treatment will be tabulated with 95% confidence intervals, by type of AE. The overall rate of grade 3-4 related AE will be computed.

  2. Response Rate [ Time Frame: 3 years ]
    Evaluation of the response rate of treated patients

  3. Overall Survival [ Time Frame: 3 years ]
    Evaluation of the overall survival of treated patients

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed non resectable stage III or IV advanced melanoma or Renal Cell Carcinoma (RCC).
  2. Patients must have a minimum of two lesions and one of which must be measurable, (it can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan).
  3. At least one tumor lesion accessible for bioptic sampling.
  4. Prior lines (maximum 4) of chemotherapy, immunotherapy or biological therapy (e.g. inhibitors of B-Raf or c-Kit, Ipilimumab, etc.) for advanced disease are allowed (patients must have finished prior treatments at least 4 weeks before the first IL2 dose);
  5. Male or Female, aged >= 18 years.
  6. Life expectancy of greater than 3 months.
  7. ECOG performance status <=1
  8. Patients must have normal organ and marrow function as defined below:

    • leukocytes >=3,500/microL
    • absolute neutrophil count >=1,500/microL
    • platelets >= 100,000/microL
    • total bilirubin within normal institutional limits
    • AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of normal
    • creatinine < 1,2 mg/dl
    • haemoglobin > 9.0 gm/dl
    • ECG and echocardiogram within normal institutional limits
    • Pulmonary function tests within normal institutional limits (to be performed only in patients with lung metastases or history of impaired lung function)
  9. no contraindication for the use of vasopressor agents
  10. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
  11. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  1. Patient with stage I or II melanoma or RCC
  2. Patients who have had chemotherapy or radiotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  3. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
  4. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in the study.
  6. Any autoimmune disease which could be exacerbated by IL-2
  7. A medical illness requiring chronic treatments with corticosteroids or other immunosuppressive agents
  8. A history of significant cardiovascular disease, including myocardial infarction, congestive heart failure, primary cardiac arrhythmias, angina pectoris or cerebrovascular accident
  9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  10. Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);
  11. HIV-positivity, whether or not symptomatic.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01884961

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Contact: Oriana Nanni, PhD +390543739266

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UO Oncologia Medica, IRCCS IRST Recruiting
Meldola (FC), FC, Italy, 47014
Contact: Laura Ridolfi, MD         
Principal Investigator: Laura Ridolfi, MD         
Sponsors and Collaborators
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
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Principal Investigator: Laura Ridolfi, MD IRST IRCCS, Meldola
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori Identifier: NCT01884961    
Other Study ID Numbers: IRST172.03
2012-001786-32 ( EudraCT Number )
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases