Tumor Infiltrating Lymphocytes Adjuvant Therapy of Melanoma

NCT00200577 | Completed Phase 3

• 1 other identifier: BRD/04/01-D
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 9

Brief Summary

The objective of this multicentric Phase III study is to confirm the results of the phase I-II study (Dreno B \& Al. Cancer Immunol Immunother 2002; 51: 539-456) which demonstrated the preventive effect of a treatment by TIL (Tumor Infiltrating Lymphocytes) combined with IL2 (Interleukin 2; low dose injected subcutaneously) on the metastatic relapse in the stage III melanoma patients with only one invaded lymphnode.

Conditions

Melanoma

Keywords

Adjuvant therapy; immunotherapy; TIL; melanoma

Outcome Measures

Primary Outcomes (4)

• Determination of the duration of the relapse-free interval.

  5 years

• Physical examination, every 2 months until M18 then every 3 months until M36 then every 4 months up to 5 years, then once per year with a clinical examination only.

  every 2 months until M18then every 3 months until M36 then every 4 months up to 5 years

• Abdominal echography will be performed at the screening visit, M4, M8, M12 and then every 6 months until 5ans.

  M4, M8, M12 and then every 6 months until 5ans.

• CT-Scan will be performed before the first administration of study treatment (at the time of screening visit), every 6 months during 2 years and then every years up to 5 years.

  every 6 months during 2 years and then every years up to 5 years.

Secondary Outcomes (4)

• Determine of overall survival

  5 years

• To define safety and toxicity of TIL/IL2 treatment

  5 years

• Evaluation of immunological responses

  M0, J56, M12

• Analysis of the clinical, biological and histological factors on the survival of the patients

  at inclusion and each month

Study Arms (2)

TIL+IL2

EXPERIMENTAL

TIL + IL2

Drug: TIL + IL2

control

NO INTERVENTION

Patients are not treated

Interventions

TIL + IL2 DRUG

Patients are treated with 2 injections Of TIL (1st injection M1 and the second M2)The received concomitant IL2 at M1 and M2 on days Jo (injection TIL) to J5 and J8 to J12

TIL+IL2

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Melanoma stage III (regional lymph node recurrence). Will be selected the patients with only one invaded lymph node confirmed by anatomopathological exam after lymph nodes excision.
• Absence of visceral metastases verified by physical examination, chest radiography, liver echography and brain-chest-liver CT-Scan.
• Age \< 75 years, both genders
• ECOG 0-2, Karnofsky \> 80%.
• Negative pregnancy test performed at the screening visit for fertile women.
• The potentially fertile women must use an oral contraception or an intra-uterine device (IUD) until three months following the last injection of the study treatment.
• The patients must have fully recovered from surgery.
• HIV 1/2: The patients must be negative for antibodies HIV 1 and HIV 2 and for Ag P24 or DGV HIV.
• HBV: The patients must be negative for the antigen, but can be positive for the antibodies but with a negative DNA PCR.
• HCV: The patients must be negative for the antibodies.
• HTLV ½: The patients must be negative for the antibodies.
• Following laboratory results:
• Hemoglobin: ≥ 10 g/dl
• WBC: ≥ 4000/µl
• Lymphocytes: ≥ 700/µl

You may not qualify if:

• Patient with more than one invaded lymph node confirmed by anatomopathological exam.
• Presence of melanoma metastases discovered by clinical or radiological examination at the screening visit.
• Patients must not have received any Chemotherapy, immunotherapy or radiotherapy within the preceding 4 weeks (6 weeks since prior nitrosurea and mitomycin C therapies).
• Presence of cardiac affections (congestive cardiac insufficiency, coronaropathy, not controlled HTA).
• Any serious active medical illnesses, for example: Active systemic infections requiring of antibiotics, coagulation disorders or any other condition which requires concomitant medications not allowed during this study.
• Presence of the second active cancer other than surgically cured non-melanoma skin cancer or cervical carcinoma in-situ.
• Any affection requiring a systemic corticotherapy or a treatment by Interferon A.
• Thyroid dysfunction not responsive to therapy.
• Positive Serology for HIV, HVB, HVC or HTLV1/2.
• Woman pregnant or nursing or without an effective contraception.
• Incapacity to give written consent.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (9)

CHU Angers

Angers, France

Location

CHU Caen

Caen, France

Location

Grenoble University Hospital

Grenoble, France

Location

CH Le Mans

Le Mans, France

Location

Montpellier University Hospital

Montpellier, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Rennes

Rennes, France

Location

CHRU Tours

Tours, France

Location

MeSH Terms

Conditions

Melanoma

Interventions

Toll-Like Receptor 1; Interleukin-2

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Toll-Like Receptors; Receptors, Pattern Recognition; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Lymphokines; Biological Factors

Study Officials

• Brigitte DRENO, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: May 1, 2005
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 1, 2017

Record last verified: 2017-05

Locations

FR (9)