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AzTrials

Melanoma (Skin)Phase 2NCT00085423

Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma

A Phase 2 study testing aldesleukin, sargramostim and cyclophosphamide in people with Melanoma (Skin), run by Dartmouth-Hitchcock Medical 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
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells and may help a person's immune system recover from the side effects of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
aldesleukin, sargramostim and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Feb 2004to Feb 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically confirmed melanoma
  • Metastatic disease
  • Measurable disease
  • No history of brain metastases
  • Over 18
  • Karnofsky 60-100%
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  • Life expectancy At least 12 weeks
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin ≥ 8.5 g/dL
  • aspartate aminotransferase ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • Bilirubin ≤ 2 times ULN (except for patients with Gilbert's syndrome)
  • Hepatitis B and C negative
  • Creatinine ≤ 2.0 times ULN
  • Creatinine clearance ≥ 50 mL/min
  • Cardiovascular
  • Ejection fraction ≥ 50%
  • No evidence of congestive heart failure
  • No symptoms of coronary artery disease
  • No serious cardiac arrhythmias
  • No myocardial infarction within the past 6 months
  • Cardiac stress test negative or of low probability for patients > 40 years of age OR who have had prior myocardial infarction > 6 months ago
  • Pulmonary Forced expiratory volume 1 ≥ 2.0 liters OR at least 75% of predicted for height and age
  • Diffusing capacity of lung for carbon monoxide ≥ 60%
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative

Who cannot join

  • No uncontrolled diabetes
  • No history of autoimmune disease
  • No active infection
  • No other concurrent significant illness that would preclude study participation
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or non-invasive cancer (e.g., carcinoma in situ of the cervix, superficial bladder cancer without local recurrence, or carcinoma in situ of the breast)
  • At least 4 weeks since prior immunotherapy and recovered
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  • No other concurrent anticancer biologic agents
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  • No concurrent chemotherapy
  • At least 4 weeks since prior steroid therapy
  • No concurrent corticosteroids
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy
  • At least 4 weeks since prior surgery and recovered
  • No concurrent immunosuppressive therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

Other trials in United States

About this study

Official title: High Dose Interleukin-2 (IL-2) Therapy In "Lymphodepleted Primed" Patients With Metastatic Melanoma

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with high-dose interleukin-2 works in treating patients with metastatic melanoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the objective response rate in lymphodepleted patients with metastatic melanoma treated with cyclophosphamide, fludarabine, and high-dose interleukin-2.
  • Determine the feasibility of this regimen in these patients.

Secondary

  • Determine the quality and quantity of lymphocyte recovery in these patients during and after treatment with this regimen.
  • Determine time to disease progression and survival in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive lymphodepleting therapy comprising cyclophosphamide IV over 1 hour on days 1 and 2 and fludarabine IV over 30 minutes on days 3-7. Patients then receive high-dose interleukin-2 IV every 8 hours (14 doses) on days 8-12 and 22-26. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 8 and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study.

Conditions
Melanoma (Skin)
Keywords
recurrent melanoma, stage IV melanoma
Medical subject headings
Melanoma

What participants receive

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

  • aldesleukinBiological

    Also called Aldesleukin; IL-2; HD IL-2; Interleukin-2

    ‡Interleukin-2 (aldesleukin) IV (600,000 U/kg; Chiron, Emeryville, CA): two 5-day courses on days 8 and 22. Interleukin-2 was given over 15 minutes every 8 hours. Goal is 14 doses/5-day course

  • sargramostimBiological

    Also called GM-CSF; granulocyte-macrophage colony-stimulating factor

    GM-CSF was given subcutaneously daily from day 8 until absolute granulocyte count exceeds 5,000 cells/mL for 2 consecutive days.

  • cyclophosphamideDrug

    Also called cyclophosphamide,Cytoxan

    Cyclophosphamide (60 mg/kg/d; Baxter, Deerfield, IL) intravenously (IV) for 2 days with sodium 2- mercaptoethanesulfonate (Mesna; Sicor, Irvine, CA) at 20% of cyclophosphamide dose IV 15 minutes before and 40% of the cyclophosphamide dose orally at 2 and 6 hours after the initiation of chemotherapy.

  • fludarabine phosphateDrug

    Also called Fludara

    Fludarabine IV (25 mg/M2/day)-five daily doses from Day 3

Study groups in NCT00085423
Study groupRoleWhat they receive
IL-2, CTX, fludarabine, GM-CSFExperimentalAldesleukin (IL-2), cyclophosphamide, fludarabine phosphate, sargramostim
Receives: Biological: aldesleukin; Biological: sargramostim; Drug: cyclophosphamide; Drug: fludarabine phosphate

What is being measured

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

  1. Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST

    Objective response as measured by radiological and physical examination using RECIST criteria.

    Measured: Response at 12 weeks

Secondary outcomes (2)

  1. Number of Participants With Lymphocyte Recovery as Measured by Blood Count

    Lymphocyte recovery to a greater than 1000 cells/mcL was determined by differential peripheral blood cell counts on sequential days as noted in time frame.

    Measured: on days 1-15, weekly for 2 weeks, and then every 2-3 months

  2. Time to Progression as Measured by RECIST

    Clinical outcome used the National Cancer Institute's Response Evaluation Criteria in Solid Tumors (RECIST)1.0.

    Measured: From date of randomization until the first date of documented progression or date of death from any cause, which ever came first, assessed up till 100 months

Timeline

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

  1. First posted11 Jun 2004 (estimated)
  2. Study startFeb 2004
  3. Primary completionDec 2008
  4. Study completionFeb 2010

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00085423
Sponsor's protocol ID
CDR0000370788
Other IDs
P30CA023108, DMS-0320, DMS-16531
Status last verified
Apr 2013
First submitted
10 Jun 2004
Last updated
10 Apr 2013
Data monitoring committee
Yes

Publications

  • Gunturu KS, Meehan KR, Mackenzie TA, Crocenzi TS, McDermott D, Usherwood EJ, Margolin KA, Crosby NA, Atkins MB, Turk MJ, Ahonen C, Fuse S, Clark JI, Fisher JL, Noelle RJ, Ernstoff MS. Cytokine working group study of lymphodepleting chemotherapy, interleukin-2, and granulocyte-macrophage colony-stimulating factor in patients with metastatic melanoma: clinical outcomes and peripheral-blood cell recovery. J Clin Oncol. 2010 Mar 1;28(7):1196-202. doi: 10.1200/JCO.2009.24.8153. Epub 2010 Feb 1.

    PubMed 20124177

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aldesleukin, sargramostim and cyclophosphamide in people with Melanoma (Skin), run by Dartmouth-Hitchcock Medical 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 29 inclusion and 15 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 10 Apr 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?

Yes. Results are posted in the registry (first posted 10 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST (time frame: Response at 12 weeks). 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 NCT00085423, which also lists 1 linked publication.

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 10 Apr 2013.

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