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Recurrent MelanomaPhase 1/2NCT00553306

Laboratory-Treated T Cells and Aldesleukin After Cyclophosphamide in Treating Patients With Stage IV Melanoma

A Phase 1/2 study testing therapeutic autologous lymphocytes, aldesleukin and cyclophosphamide in people with Recurrent Melanoma and Stage IV Melanoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Laboratory-treated T cells may be able to kill tumor cells when they are put back into the body. Aldesleukin and cyclophosphamide may stimulate the immune system in different ways and stop tumor cells from growing. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Recurrent Melanoma, Stage IV Melanoma
What is being tested?
therapeutic autologous lymphocytes, aldesleukin and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Sep 2007to Mar 2012
Phase
Phase 1/2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathologically documented metastatic melanoma
  • Karnofsky Performance status of at least 70%
  • Expected survival of greater than 16 weeks
  • WBC > 2,500/uL (ANC > 1,000 uL)
  • Platelet count > 80,000 uL
  • HCT > 28%
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  • Patients whose tumor expresses targeted antigen and restricting allele against which CD4 and CD8 T cell clones can be generated
  • No CNS metastasis
  • Patient's whose tumor expresses an antigen and HLA type for which both an HLA Class I and HLA Class II epitope are listed, will be eligible for this study
  • CD4 and CD8 T cell clones do not necessarily have to target the same antigen to be eligible for the study, it is only necessary that the targeted antigen is expressed by the tumor and its epitope is restricted by an HLA allele expressed by the patient
  • Evidence of measurable residual disease by clinical exam or imaging studies

Who cannot join

  • Current central nervous system metastases; patients with history of CNS metastases that show no current evidence of active disease are eligible
  • Patients with active infections or oral temperature > 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy
  • Current treatment with steroids
  • Patients who are HIV seropositive (poor CD4 T cell generation due to low CD4 T cell recovery and likely HIV reservoir in stimulator cells used in vitro culture)
  • Prognosis less than 6 months
  • FOR T CELL INFUSION:
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  • Pregnant women, nursing mothers of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to entry
  • Serum creatinine > 2.0 mg/dL
  • Significant hepatic dysfunction (hepatic toxicity >= grade 2 (NCICTC) of whatever origin
  • Clinically significant pulmonary dysfunction, as determined by medical history and physical exam; patients so identified will undergo pulmonary functions testing and those with FEV1 < 60% of normal or DLco (corr for Hgb) < 55% will be excluded
  • Significant cardiovascular abnormalities as defined by any one of the following: congestive heart failure, clinically significant hypotension, symptoms of coronary artery disease, presence of cardiac arrhythmias on EKG requiring drug therapy
  • Ejection fraction < 50% excludes patients
  • Current central nervous system metastases; patients with history of CNS metastases that show no current evidence of active disease are eligible
  • Serum calcium > 12 mg/dL
  • Chemotherapeutic agents (standard or experimental), radiation therapy, or other immunosuppressive therapies less than 4 weeks prior to T cell therapy; patients with bulky disease may undergo 1-2 courses of cytoreductive chemotherapy but treatment will be discontinued at least 4 weeks prior to T cell therapy; patients should have recovered fully from all previous treatment-related toxicities
  • History of seizures
  • Patients must not be receiving any other experimental drugs within 4 weeks of the initiation of the protocol and must have recovered from all side effects of such therapy
  • Patients with >= Grade 2 hepatotoxicity are excluded
  • Patients with a history of autoimmune disease requiring active systemic therapy are excluded
  • The following agents are not allowed while on study: systemic corticosteroids (except as outlined for management of toxicity of nontransduced CTL), immunotherapy (for example, interleukins, interferons, melanoma vaccines, intravenous immunoglobulin, expanded polyclonal TIL or LAK therapy), pentoxifylline, or other investigational agents

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Phase I Study To Evaluate Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Cyclophosphamide Conditioning For Patients With Metastatic Melanoma

RATIONALE: Laboratory-treated T cells may be able to kill tumor cells when they are put back into the body. Aldesleukin and cyclophosphamide may stimulate the immune system in different ways and stop tumor cells from growing. Giving laboratory-treated T cells together with aldesleukin after cyclophosphamide may be an effective treatment for melanoma.

PURPOSE: This phase I/II trial is studying the side effects of giving laboratory-treated T cells together with aldesleukin after cyclophosphamide and to see how well they work in treating patients with stage IV melanoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the safety and toxicity of cellular adoptive immunotherapy in melanoma patients using autologous CD4+ and CD8+ antigen-specific T cell clones.

II. To evaluate the antitumor effects of CD4+ and CD8+ antigen-specific T cells in patients with metastatic melanoma.

III. To determine the duration of in vivo persistence of adoptively transferred CD8+ antigen-specific T cell clones in the presence or absence of transferred CD4+ T cells.

SECONDARY OBJECTIVES:

  1. To assess the in vivo antitumor efficacy of the infused autologous antigen-specific CD4+ T cells.

OUTLINE: This is a phase I study followed by a phase II study.

Beginning 48 hours before T-cell infusion, patients receive cyclophosphamide IV. Patients then receive antigen-specific CD8+ T cells IV alone or with CD4+ T helper clones over 1-2 hours on day 0. Patients also receive aldesleukin subcutaneously twice daily on days 0-13. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up weekly for 8 weeks, and then periodically thereafter.

Being tested
therapeutic autologous lymphocytes, aldesleukin, cyclophosphamide, biopsy, immunohistochemistry staining method
Medical subject headings
Melanoma

What participants receive

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

  • therapeutic autologous lymphocytesBiological

    Also called AL, Autologous Lymphocytes, autologous T cells

    Given IV

  • aldesleukinBiological

    Also called IL-2, interleukin II, Proleukin, recombinant human interleukin-2

    Given subcutaneously

  • cyclophosphamideDrug

    Also called CPM, CTX, Cytoxan, Endoxan

    Given IV

  • biopsyProcedure or surgery

    Also called biopsies

    Optional correlative studies

  • immunohistochemistry staining methodOther

    Also called immunohistochemistry

    Optional correlative studies

  • flow cytometryOther

    Correlative studies

  • polymerase chain reactionGenetic

    Also called PCR

    Correlative studies

Study groups in NCT00553306
Study groupRoleWhat they receive
Arm IExperimentalBeginning 48 hours before T-cell infusion, patients receive cyclophosphamide IV. Patients then receive antigen-specific CD8+ T cells IV alone or with CD4+ T helper clones over 1-2 hours on day 0. Patients also receive aldesleukin subcutaneously twice daily on days 0-13. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: therapeutic autologous lymphocytes; Biological: aldesleukin; Drug: cyclophosphamide; Procedure: biopsy; Other: immunohistochemistry staining method; Other: flow cytometry; Genetic: polymerase chain reaction

What is being measured

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

  1. Safety and toxicity as assessed by NCI CTC version 3.0

    Measured: 8 weeks post treatment

  2. Antitumor effects of CD4+ and CD8+ antigen-specific T-cells

    Measured: 8 weeks post treatment

  3. Duration of in vivo persistence of adoptively transferred CD8+ antigen-specific T cell clones in the presence or absence of transferred CD4+ T cells

    Measured: 8 weeks post treatment

Secondary outcomes (1)

  1. In vivo antitumor efficacy of the infused autologous antigen-specific CD4+ T cells

    Measured: 8 weeks post treatment

Timeline

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

  1. First posted5 Nov 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionAug 2010
  4. Study completionMar 2012

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00553306
Sponsor's protocol ID
2179.00
Other IDs
NCI-2010-01281
Status last verified
Feb 2017
First submitted
2 Nov 2007
Last updated
15 Feb 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing therapeutic autologous lymphocytes, aldesleukin and cyclophosphamide in people with Recurrent Melanoma and Stage IV Melanoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

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 11 inclusion and 20 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: finished, as of the sponsor's last update on 15 Feb 2017. 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 United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and toxicity as assessed by NCI CTC version 3.0 (time frame: 8 weeks post treatment). The study lists 3 primary outcomes in all. 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 NCT00553306.

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 15 Feb 2017.

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