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ALDE(Intralesional)

Cancer Type: Skin, Melanoma  Intent: Palliative, Curative
Regimen Category: Evidence-Informed
Funding:
New Drug Funding Program
    Aldesleukin (interleukin-2) - In-Transit Metastases from Melanoma
A - Regimen Name

ALDE(Intralesional) Regimen
Aldesleukin


Disease Site
Skin - Melanoma

Intent
Palliative
Curative

Regimen Category
Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.


Rationale and Uses

For the treatment of in-transit metastases from melanoma in patients who have failed or are not candidates for surgery or other treatments.

This recommendation is based on phase II studies that showed improvements in complete response; an overall survival benefit has not be demonstrated.


Supplementary Public Funding

aldesleukin
New Drug Funding Program (Aldesleukin (interleukin-2) - In-Transit Metastases from Melanoma) (NDFP Website)

 
B - Drug Regimen

The amount injected depends on the number and size of in-transit metastases. Doses should not exceed 1 vial (22 million IU) per cycle.

aldesleukin
up to 22 million IU Intralesional
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C - Cycle Frequency

REPEAT EVERY 7 TO 14 DAYS

Curative: For a total of 8 cycles

Palliative: Until disease progression or lesion regression

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal

Other Supportive Care:

Also refer to CCO Antiemetic Recommendations.

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated.

Dosage with toxicity

Aldesleukin is generally well-tolerated. In one study, the drug was discontinued if lesions were enlarging despite injection or if there was no visible response by the fourth injection (Boyd et al. 2011).



Hepatic Impairment

Hold until recovery if any signs of hepatic failure are present.

Renal Impairment

Do not start treatment if serum creatinine > 130 µmol/L.


 
F - Adverse Effects

Refer to aldesleukin drug monograph(s) for additional details of adverse effects


Most Common Side Effects 

Less Common Side Effects, but may be
Severe or Life-Threatening

  • Injection-site reaction
  • Flu-like symptoms (fever, fatigue)
  • Nausea, vomiting
  • Arrhythmia
  • Hypersensitivity
 
 
G - Interactions

Refer to aldesleukin drug monograph(s) for additional details


Glucocorticoids may reduce the anti-tumour effect of aldesleukin.

 
H - Drug Administration and Special Precautions

Refer to aldesleukin drug monograph(s) for additional details


Administration

  • Reconstitute vial with 1.2 mL of SWFI and swirl gently to mix. DO NOT shake.
  • Dilute with D5W to desired concentration.
  • Withdraw into syringes for intralesional administration per local protocol.
  • Store reconstituted drug between 2 to 8oC for up to 48 hours. DO NOT freeze.

Contraindications

  • hypersensitivity to aldesleukin, interleukin-2, or any other components of the product
 
I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Recommended Clinical Monitoring

  • CBC; baseline and as clinically indicated
  • CT scan of brain to exclude CNS metastases; baseline
  • Electrolytes; baseline and as clinically indicated
  • Liver and renal function tests; baseline and as clinically indicated
  • Clinical toxicity assessment for flu-like symptoms, injection site reactions, hypersensitivity; at each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


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J - Administrative Information

Pharmacy Workload (average time per visit)
47.350 minutes
 
K - References

Aldesleukin drug monograph, Cancer Care Ontario.

Boyd KU, Wehrli BM, Temple CL. Intra-lesional interleukin-2 for the treatment of in-transit melanoma. J Surg Oncol. 2011 Dec;104(7):711-7.

Hassan S, Petrella TM, Zhang T, et al.  Pathologic complete response to intralesional interleukin-2 therapy associated with improved survival in melanoma patients with in-transit disease.  Ann Surg Oncol 2015;22(6):1950-8.

pCODR Expert review committee final recommendation. Aldesleukin for in-transit melanoma. May 2015.

Weide B, Derhovanessian E, Pflugfelder A, et al. High response rate after intratumoral treatment with interleukin-2: results from a phase 2 study in 51 patients with metastasized melanoma. Cancer. 2010 Sep 1;116(17):4139-46.
 

May 2019 Updated emetic risk category


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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.