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Recurrent MelanomaPhase 2NCT00303836

Vaccine Therapy With or Without Interleukin-2 After Chemotherapy and an Autologous White Blood Cell Infusion in Treating Patients With Metastatic Melanoma

A Phase 2 study testing cyclophosphamide, fludarabine phosphate and therapeutic autologous lymphocytes in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized phase II trial is studying how well giving vaccine therapy with or without interleukin-2 after chemotherapy and an autologous white blood cell infusion works in treating patients with metastatic melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Melanoma, Stage IV Melanoma
What is being tested?
cyclophosphamide, fludarabine phosphate and therapeutic autologous lymphocytes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
Nov 2005to Jan 2007
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

  • Diagnosis of metastatic melanoma
  • No tumor reactive cells available for cell transfer therapy
  • Measurable disease
  • Previously treated with interleukin-2 (IL-2) and meets 1 of the following criteria:
  • No response (progressive disease)
  • Recurrent disease
Show all 32Show fewer
  • HLA*0201 positive
  • ECOG performance status 0 or 1
  • Absolute neutrophil count > 1,000/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 8.0 g/dL
  • ALT and AST < 3 times upper limit of normal
  • Bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL if Gilbert's disease is present)
  • Creatinine ≤ 2.0 mg/dL
  • Life expectancy ≥ 3 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 4 months after receiving the preparative regimen
  • No active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, or obstructive or restrictive pulmonary disease
  • No autoimmune disease (e.g., autoimmune colitis or Crohn's disease) or primary immunodeficiency disease
  • No HIV positivity
  • No hepatitis B or C virus positivity
  • No Epstein-Barr virus negativity
  • Eligible to receive high-dose IL-2, as evidenced by the following:
  • Patients ≥ 50 years of age must have a normal cardiac stress test (e.g., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) AND LVEF ≥ 45%
  • Patients with a history of EKG abnormalities, symptoms of cardiac ischemia, or arrhythmias must have a normal cardiac stress test AND LVEF ≥ 45%
  • Patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction must have a normal pulmonary function test, as evidenced by FEV 1 ≥ 60% of predicted
  • At least 4 weeks since prior systemic therapy
  • At least 6 weeks since prior nitrosourea therapy
  • No concurrent systemic steroid therapy
  • Recovered immune competence after prior chemotherapy or radiotherapy
  • No prior gp100:209-217 or MART-1:27-35 peptide vaccine

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Cancer Institute Surgery Branch

    Bethesda, Maryland, 20892-1201

Other trials in United States

About this study

Official title: A Phase II Study Using a Peptide Vaccine With or Without Aldesleukin Following a Lymphodepleting Chemotherapy and Reinfusion of Autologous Lymphocytes Depleted of T Regulatory Lymphocytes in Metastatic Melanoma

This randomized phase II trial is studying how well giving vaccine therapy with or without interleukin-2 after chemotherapy and an autologous white blood cell infusion works in treating patients with metastatic melanoma. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy with interleukin-2, chemotherapy, and an autologous white blood cell infusion may be a more effective treatment for metastatic melanoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the ability of gp100 and MART-1 peptide vaccines with or without a high-dose interleukin-2 (IL-2), when administered after a nonmyeloablative, lymphodepleting preparative regimen and reinfusion of autologous CD25+ T-regulatory-depleted lymphocytes, to mediate tumor regression in patients with metastatic melanoma.

SECONDARY OBJECTIVES:

  1. Determine the generation of antitumor lymphocytes and the rate of repopulation of CD25+ T-regulatory cells in patients treated with this regimen.

II. Determine the toxicity of this treatment regimen.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo apheresis and in-vitro depletion of T-regulatory cells. Patients then receive a nonmyeloablative, lymphocyte-depleting preparative regimen comprising cyclophosphamide IV over 1 hour on days -8 and -7 and fludarabine IV over 15-30 minutes on days -6 to -2 followed by autologous T-regulatory-depleted lymphocytes IV over 20-30 minutes on day 0. Patients receive vaccination with gp100:209-217 (210M) and MART-1:27-35 peptides emulsified in Montanide ISA-51 subcutaneously (SC) on days 0-3, 20-23, 41-44, and 62-65. Patients also receive filgrastim (G-CSF) SC beginning on day 1 and continuing until blood counts recover.

ARM II: Patients receive treatment as in arm I. Patients also receive high-dose IL-2 IV over 15 minutes every 8 hours on days 0-4, beginning after the lymphocyte infusion. IL-2 treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 1-3 months.

Being tested
cyclophosphamide, fludarabine phosphate, therapeutic autologous lymphocytes, in vitro-treated peripheral blood stem cell transplantation, gp100 antigen
Medical subject headings
Melanoma

What participants receive

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

  • cyclophosphamideDrug

    Also called CPM, CTX, Cytoxan, Endoxan

    Given IV

  • fludarabine phosphateDrug

    Also called 2-F-ara-AMP, Beneflur, Fludara

    Given IV

  • therapeutic autologous lymphocytesBiological

    Also called AL, Autologous Lymphocytes, autologous T cells

    Given IV

  • in vitro-treated peripheral blood stem cell transplantationProcedure or surgery

    Also called in vitro-treated PBPC transplantation, in vitro-treated PBSC, in vitro-treated peripheral blood progenitor cell transplantation, PBPC transplantation, in vitro-treated

    Undergo in vitro-treated peripheral blood stem cell transplantation

  • gp100 antigenBiological

    Also called gp100

    Given SC

  • MART-1 antigenBiological

    Also called Antigen LB39-AA, Antigen SK29-AA, MART-1, MART-1 Tumor Antigen

    Given SC

  • incomplete Freund's adjuvantBiological

    Also called IFA, ISA-51, Montanide ISA 51

    Given SC

  • filgrastimBiological

    Also called G-CSF, Neupogen

    Given SC

  • aldesleukinBiological

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

    Given IV

Study groups in NCT00303836
Study groupRoleWhat they receive
Arm IExperimentalPatients undergo apheresis and in-vitro depletion of T-regulatory cells. Patients then receive a nonmyeloablative, lymphocyte-depleting preparative regimen comprising cyclophosphamide IV over 1 hour on days -8 and -7 and fludarabine IV over 15-30 minutes on days -6 to -2 followed by autologous T-regulatory-depleted lymphocytes IV over 20-30 minutes on day 0. Patients receive vaccination with gp100:209-217 (210M) and MART-1:27-35 peptides emulsified in Montanide ISA-51 subcutaneously (SC) on days 0-3, 20-23, 41-44, and 62-65. Patients also receive filgrastim (G-CSF) SC beginning on day 1 and continuing until blood counts recover.
Receives: Drug: cyclophosphamide; Drug: fludarabine phosphate; Biological: therapeutic autologous lymphocytes; Procedure: in vitro-treated peripheral blood stem cell transplantation; Biological: gp100 antigen; Biological: MART-1 antigen; Biological: incomplete Freund's adjuvant; Biological: filgrastim
Arm IIExperimentalPatients receive treatment as in arm I. Patients also receive high-dose IL-2 IV over 15 minutes every 8 hours on days 0-4, beginning after the lymphocyte infusion. IL-2 treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cyclophosphamide; Drug: fludarabine phosphate; Biological: therapeutic autologous lymphocytes; Procedure: in vitro-treated peripheral blood stem cell transplantation; Biological: gp100 antigen; Biological: MART-1 antigen; Biological: incomplete Freund's adjuvant; Biological: filgrastim; Biological: aldesleukin

What is being measured

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

  1. Objective clinical response (CR or PR)

    Measured: Up to 2 years

Secondary outcomes (3)

  1. Presence of anti-tumor T cells

    Measured: Up to 2 years

  2. Recovery of regulatory T cells

    Measured: Up to 2 years

  3. Incidence of DLTs and SAEs graded according to CTCAE version 3.0

    Measured: Up to 2 years

Timeline

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

  1. First posted17 Mar 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionJan 2007

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303836
Sponsor's protocol ID
NCI-2012-02684
Other IDs
P6574, NCI-06-C-0028, CDR0000459683, NCI-7547, NCI-P6574
Status last verified
Jun 2013
First submitted
15 Mar 2006
Last updated
6 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cyclophosphamide, fludarabine phosphate and therapeutic autologous lymphocytes in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) 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 32 inclusion and 0 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: stopped early, as of the sponsor's last update on 6 Jun 2013. 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 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?

The study was stopped early. Results are not available in the source record.

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?

Objective clinical response (CR or PR) (time frame: Up to 2 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 NCT00303836.

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 6 Jun 2013.

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