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Metastatic MelanomaPhase 2NCT00604136

Treatment of Metastatic Melanoma With Tumor Infiltrating Lymphocytes and IL-2 Following Lympho-depleting Chemotherapy

A Phase 2 study testing tumor infiltrating lymphocytes in people with Metastatic Melanoma, run by Hadassah Medical Organization at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Prior preclinical and clinical studies have shown that tumors from patients with advanced melanoma contain tumor-infiltrating lymphocytes (TIL) with anti-tumor reactivity. These TIL can be expanded in the laboratory to large numbers, and reinfused to the patient. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
tumor infiltrating lymphocytes
Type of treatment
Injection or infusion
How many people
20 participants
Where
1 siteIsrael
Study dates
Jul 2008to Jul 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have metastatic melanoma with a resectable metastatic lesion of sufficient size and be willing to undergo such a resection for experimental purposes. For HLA-A0201+ patients, lesions must be > 1.5 cm in diameter and for HLA-A0201- patients, lesions must be > 3 cm in diameter.
  • Patients must be > 18 years of age and must have measurable metastatic melanoma (in addition to the resected lesion).
  • Patients of both genders must be willing to practice birth control during treatment and for four months after receiving the preparative regimen.
  • Clinical performance status of ECOG 0, 1.
  • Absolute neutrophil count greater than 1000/mm3 without support of filgrastim.
  • Platelet count greater than 100,000/mm3.
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  • Serum ALT/AST less than three times the upper limit of normal.
  • Serum creatinine less than or equal to 1.6 mg/dl.
  • Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 mg/dl.
  • Patients must be able to understand and sign the Informed Consent document

Who cannot join

  • Tumor/TIL Harvest Exclusion Criteria:
  • Less than 4 weeks has elapsed since any prior systemic therapy or less than six weeks since prior nitrosourea therapy
  • Women who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
  • Life expectancy of less than three months.
  • Patients who have received prior treatment with anti-CTLA-4 antibody will be excluded unless a post anti-CTLA-4 antibody treatment colonoscopy was normal with normal colonic biopsies.
  • Patients who require immediate active treatment for symptomatic CNS lesions will not be eligible until after treatment of their symptomatic lesions.
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  • Cell Infusion Exclusion Criteria:
  • Less than 4 weeks has elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, or less than six weeks since prior nitrosourea therapy. All patients' toxicities must have recovered to a grade 1 or less or as specified in the eligibility criteria. Patients may have undergone minor surgical procedures or focal palliative radiotherapy (to non-target lesions) within the past 4 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the eligibility criteria.
  • Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
  • Life expectancy of less than three months.
  • Requirement for systemic steroid therapy.
  • Hemoglobin less than 8g/dl unable to be corrected with transfusion.
  • Any active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
  • Any form of primary or secondary immunodeficiency. Must have recovered immune competence after chemotherapy or radiation therapy as evidenced by normal ANC > 1000/mm3 and absence of opportunistic infections. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
  • Seropositive for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus are less responsive to the experimental treatment and more susceptible to its toxicities.)
  • Patients with hepatitis B or hepatitis C will be excluded.
  • The following patients will be excluded because of inability to receive high dose interleukin-2:
  • Patients will be excluded if they have a history of major EKG abnormalities, symptoms of cardiac ischemia or arrhythmias and have a LVEF < 45% on a cardiac stress test (stress thallium, stress MUGA, dobutamine, echocardiogram or other stress test)
  • Similarly, patients who are 50 years old or greater with an LVEF < 45% will be excluded
  • Patients who have a prolonged history of cigarette smoking or symptoms of respiratory dysfunction will be excluded if they have an abnormal pulmonary function test as evidenced by a FEV1 < 60% predicted.
  • Patients who have received prior treatment with anti-CTLA-4 antibody will be excluded unless a subsequent colonoscopy was normal with normal colonic biopsies (to rule out colitis).
  • Patients who require immediate treatment for symptomatic CNS lesions will not be eligible until after treatment of their symptomatic lesions and resolution of symptoms.

Trial locations and contacts

1 site in 1 country.

Michal Lotem, MD contact

972508573528

mlotem@hadassah.org.il

Israel1 site, 1 recruiting

  • Hadassah Medical Organization, Jerusalem, Israel

    Jerusalem, 91120

    Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il

    Shoshana Frankenburg, PhD

    Recruiting

Other trials in Israel

About this study

Official title: Treatment of Metastatic Melanoma Patients With Tumor Infiltrating Lymphocytes and IL-2 Following a Regimen of Non-myeloablative Lymphocyte Depleting Chemotherapy

Prior preclinical and clinical studies have shown that tumors from patients with advanced melanoma contain tumor-infiltrating lymphocytes (TIL) with anti-tumor reactivity. These TIL can be expanded in the laboratory to large numbers, and reinfused to the patient. Using a chemotherapy regimen that selectively kills lymphocytes, a single institution Phase II study of 35 patients showed a 51% objective response rate to TIL and interleukin-2 injection. In the present trial we would like to investigate whether we can achieve similar results in a Hadassah Phase II study, and to determine the feasibility of applying this approach to patients with advanced melanoma who currently have few treatment options.

Being tested
tumor infiltrating lymphocytes
Keywords
melanoma, tumor infiltrating lymphocytes, interleukin-2
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tumor infiltrating lymphocytesBiological

    Patients will have a melanoma metastasis resected and cultured in IL-2 in vitro. Tumor infiltrating lymphocytes from these cultures will be assessed for tumor reactivity and those with such activity will be further expanded and adoptively transferred. Patients will receive a non-myeloablative lymphocyte-depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x2 days IV)and fludarabine (25 mg/mE2/day IV x5days). Following this regimen, patients will receive an intravenous adoptive transfer of at least 10E9 tumor-reactive lymphocytes followed by high dose IL-2 (720,000 IU/kg/dose IV every 8 hours for up to 15 doses).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the response rate of this approach when administered in our hospital

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionDec 2019 (estimated)
  4. Study completionJul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00604136
Sponsor's protocol ID
MS269- HMO-CTIL
Status last verified
Sep 2018
First submitted
17 Jan 2008
Last updated
18 Sep 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tumor infiltrating lymphocytes in people with Metastatic Melanoma, run by Hadassah Medical Organization at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michal Lotem, MD (972508573528, mlotem@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the response rate of this approach when administered in our hospital (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00604136.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.

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