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Melanoma (Skin)Phase 2NCT00003568

Vaccine Therapy With High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma

A Phase 2 study testing aldesleukin, gp100 antigen and incomplete Freund's adjuvant in people with Melanoma (Skin), run by University of Illinois Chicago at 9 sites 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: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with interleukin-2 in treating patients with metastatic melanoma. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
aldesleukin, gp100 antigen and incomplete Freund's adjuvant
How many people
Not given
Where
9 sitesUnited States
Study dates
Nov 1998to Dec 2005
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed clearly progressive metastatic or unresectable melanoma
  • Must be HLA-A2.1 positive
  • Measurable disease
  • No active brain metastases, leptomeningeal disease, or seizure disorder
  • More than 4 months since prior definitive therapy (surgery or radiotherapy) for brain metastases and must not have evidence of disease on brain CT scan or MRI
  • No ascites or pleural effusions

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1 OR
  • Karnofsky 80-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No congestive heart failure
  • No symptoms of coronary artery disease
  • No serious cardiac arrhythmias
  • No evidence of prior myocardial infarction on EKG
  • Normal cardiac stress test required for all patients over 40 years

Pulmonary:

  • FEV_1 greater than 2.0 liters or at least 75% of predicted
  • No chronic obstructive pulmonary disease

Other:

  • HIV negative
  • No significant systemic infection
  • No contraindication to use of pressor agents
  • No history of major psychiatric illness
  • No other major illness that would significantly increase the risk of immunotherapy
  • No other active malignancy except surgically cured nonmelanoma skin cancer or carcinoma in situ or stage I carcinoma of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior interleukin-2
  • At least 4 weeks since prior vaccine therapy or other cytokine therapy

Chemotherapy:

  • One prior chemotherapy regimen allowed
  • At least 4 weeks since prior chemotherapy (6 weeks for carmustine or lomustine) and recovered

Endocrine therapy:

  • No concurrent steroids

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy to areas of measurable disease unless there has been clearly progressive disease in this site or there is measurable disease outside of areas of prior radiation
  • At least 2 weeks since prior radiotherapy for local control or palliative therapy and recovered

Surgery:

  • See Disease Characteristics
  • Recovered from prior major surgery
  • No prior organ allografts

Other:

  • No antihypertensive therapy within 24 hours prior to interleukin-2

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites
  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of Illinois at Chicago Health Sciences Center

    Chicago, Illinois, 60612

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-0269

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-2516

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15236

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Comprehensive Cancer Center at Our Lady of Mercy Medical CenterOur

    The Bronx, New York, 10466

Other trials in United States

About this study

Official title: A Randomized Phase II Trial of a Mutated gp100 Melanoma Peptide (g209-217(210M) With Hight Dose Interleukin-2 (IL-2) in HLA-A2.1+Patients With Metastatic Melanoma

RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.

PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with interleukin-2 in treating patients with metastatic melanoma.

Read the detailed description

OBJECTIVES:

  • Define the antitumor activity of gp100:209-217 (210M), a melanoma peptide derived from gp100 mixed with Montanide ISA-51, in combination with high-dose interleukin-2 (IL-2) administered by various schedules in patients with advanced melanoma.
  • Examine the effect of the addition of gp100:209-217 (210M) peptide vaccine to high-dose IL-2 on the toxicity of the treatment in these patients.
  • Define the induction of T-cell responses to gp100:209-217 (210M) peptide and its gp100 (parent) protein by ELISA with interferon gamma production or CTL precursor frequencies in these patients after the initial course of treatment.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior therapy (adjuvant interferon vs chemotherapy for advanced disease vs both vs none), ECOG performance status (0 vs 1), and number of organ sites involved (1 vs more than 1). Patients are randomized into 1 of 3 treatment arms. (Arm III closed to accrual as of 11/30/1998.)

  • Arm I: Patients receive vaccination comprising gp100:209-217 (210M) peptide mixed with Montanide ISA-51 subcutaneously on days 1, 22, 43, and 64. Patients also receive high-dose interleukin-2 (IL-2) IV over 15 minutes every 8 hours on days 2-6 and 16-20.
  • Arm II: Patients receive vaccination as in arm I on days 1, 22, 43, and 64. Patients also receive high-dose IL-2 as in arm I on days 44-48 and 60-64. Patients who demonstrate rapid visible disease progression during the initial 4 weeks of therapy while maintaining good performance status may begin high-dose IL-2 on day 23.
  • Arm III (closed to accrual as of 11/30/1998): Patients receive vaccination as in arm I on day 1 and then high-dose IL-2 as in arm I on day 2. Patients with nonhematologic toxicity may only receive vaccination on weeks 4, 7, and 10. Other patients may also receive IL-2 beginning on day 2 of each treatment week (4, 7, and 10) for up to 14 doses.

Patients in each arm may receive up to a total of 3 courses of treatment.

Patients are followed until death.

PROJECTED ACCRUAL: Approximately 90 patients (25 patients for arms I and II and 40 patients for arm III [arm III closed to accrual as of 11/30/1998]) will be accrued for this study within 12-18 months.

Conditions
Melanoma (Skin)
Being tested
aldesleukin, gp100 antigen, incomplete Freund's adjuvant
Keywords
stage IV melanoma, recurrent 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

  • gp100 antigenBiological

  • incomplete Freund's adjuvantBiological

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 1998
  3. Study completionDec 2005

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003568
Sponsor's protocol ID
CWG-UIC-T98-0027
Other IDs
CDR0000066634, NCI-T98-0027
Status last verified
Nov 2005
First submitted
1 Nov 1999
Last updated
26 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aldesleukin, gp100 antigen and incomplete Freund's adjuvant in people with Melanoma (Skin), run by University of Illinois Chicago at 9 sites 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?

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 26 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 9 sites 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 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.

Where can I read the original study information?
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 26 Jun 2013.

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