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Phase II Study Evaluating The Infusion Of Autologous Tumor-Infiltrating Lymphocytes (TILs) And Low-Dose Interleukin-2 (IL-2) Therapy Following A Preparative Regimen Of Non-Myeloablative Lymphodepletion Using Cyclophosphamide And Fludarabine In Patients With Metastatic Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic, Stage III or Stage IV, Melanoma

Thank you

Trial Information

Phase II Study Evaluating The Infusion Of Autologous Tumor-Infiltrating Lymphocytes (TILs) And Low-Dose Interleukin-2 (IL-2) Therapy Following A Preparative Regimen Of Non-Myeloablative Lymphodepletion Using Cyclophosphamide And Fludarabine In Patients With Metastatic Melanoma

Inclusion Criteria


Inclusion Criteria (Eligibility for TIL Evaluation):

- Must have measurable, unresectable stage III or stage IV melanoma

- Suitable tumor for collection

- If tumor is suitable for collection, patient must be suitable for surgery

- Patient must be 18 years of age or older

- Performance status of ECOG 0 or 1

- Life expectancy > 5 months from date of consent of TIL evaluation

- Willing to be tested for transmissible diseases

- For patients with a history of allergy to penicillin, gentamycin, streptomycin, or
anti-fungals, the ability to generate TILs will be confirmed with the cell
manufacturing laboratory

Inclusion Criteria (Eligibility for Treatment):

- Signed and dated the informed consent

- No brain metastases or stable brain metastases for 3 months following definitive
treatment.

- Life expectancy > 3 months from the date of consent for TILs treatment

- TILs are suitable for use as determined by laboratory

- More than 30 days since any prior systemic therapy at the time of the cell infusion,
or more than six weeks since prior nitrosurea therapy. For patients with prior
ipilimumab therapy, at least six weeks must elapse between the last ipilimumab dose
and the start of study treatment. All side effects from previous treatment must have
recovered to an acceptable grade level.

- Adequate organ function

- Must have positive EBV titres

- Women of child-bearing potential must have a negative pregnancy test. Patients of
both genders must be willing to practice birth control during treatment and for 6
months post completion of IL-2 treatment.

Exclusion Criteria:

- Requiring systemic steroid therapy

- HIV positive

- With active hepatitis B or hepatitis C, syphilis, or HTLV

- Must not have any active systemic infections, coagulation disorders or other active
major medical illnesses of the cardiovascular, respiratory or immune system,
uncontrolled psychiatric disorders, or other conditions that may affect following
study procedures.

- Have no active underlying cardiac illnesses defined by positive stress test, LVEF<40%
or ongoing life-threatening arrhythmias

- Abnormal lung function test

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response to treatment

Outcome Time Frame:

6 weeks after treatment

Safety Issue:

No

Principal Investigator

Butler Marcus, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Cancer Centre

Authority:

Canada: Health Canada

Study ID:

TILs-002-MEL

NCT ID:

NCT01883323

Start Date:

June 2013

Completion Date:

December 2023

Related Keywords:

  • Metastatic, Stage III or Stage IV, Melanoma
  • Measurable
  • Unresectable
  • Stage III
  • Stage IV
  • Metastatic
  • Melanoma
  • Tumor-Infiltrating Lymphocytes
  • Low-Dose Interleukin-2
  • Cyclophosphamide
  • Fludarabine
  • Melanoma

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