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Melanoma (Skin)Phase 1NCT00037037

Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma

A Phase 1 study testing MAGE-10.A2, MART-1 antigen and NY-ESO-1 peptide vaccine in people with Melanoma (Skin), run by Herbert Irving Comprehensive Cancer Center at 1 site in United States.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells. 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?
MAGE-10.A2, MART-1 antigen and NY-ESO-1 peptide vaccine
Type of treatment
Vaccines
How many people
Not given
Where
1 siteUnited States
Study dates
Oct 2001to not given
Phase
Phase 1
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed high-risk stage III or IV melanoma
  • Stage III disease less than 6 months after surgical resection
  • Completed prior interferon alfa therapy OR
  • Progressive disease or major adverse events during prior interferon alfa therapy
  • Stage III disease at least 6 months after surgical resection
  • Declined, failed, or completed prior standard therapy
  • Stage IV disease
  • Declined, failed, or completed prior standard therapy
  • HLA-A2 positive
  • No CNS metastases unless treated and stable

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • At least 4 months

Hematopoietic:

  • Neutrophil count at least 1,500/mm3
  • Lymphocyte count at least 500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg)
  • No bleeding disorder

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • No hepatitis B or C positivity

Renal:

  • Creatinine no greater than 1.8 mg/dL

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Other:

  • HIV negative
  • No other serious illness
  • No serious infection requiring antibiotics
  • No history of immunodeficiency disease or autoimmune disease
  • No psychiatric or addictive disorder that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No prior bone marrow or stem cell transplantation
  • At least 4 weeks since prior immunotherapy or biologic therapy
  • No other concurrent immunotherapy or biologic therapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent systemic corticosteroids
  • No concurrent steroids except topical or inhalational steroids
  • Concurrent hormonal therapy allowed

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior surgery

Other:

  • At least 4 weeks since prior investigational agents
  • Concurrent noncytotoxic anticancer therapy allowed
  • No concurrent immunosuppressive therapy
  • No concurrent antihistamines
  • No concurrent non-steroidal anti-inflammatory drugs except in low doses for prevention of an acute cardiovascular event or pain control

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032

Other trials in United States

About this study

Official title: A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma.

Read the detailed description

OBJECTIVES:

  • Compare the safety of melanoma peptide vaccine with or without sargramostim (GM-CSF) in patients with high-risk or metastatic melanoma.
  • Compare changes in peptide-specific cellular and humoral immunologic profiles in patients treated with these regimens.
  • Compare tumor response in patients treated with these regimens.

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

  • Arm I: Patients receive melanoma peptide vaccine comprising tyrosinase leader injected at 2 separate sites, Melan-A ELA injected at another site, NY-ESO-1a and NY-ESO-1b combined and injected at one site, and MAGE-10.A2 injected at another site, intradermally once weekly on weeks 1-6.
  • Arm II: Patients receive vaccine as in arm I. Patients also receive sargramostim (GM-CSF) subcutaneously daily beginning 2 days before each vaccination and continuing for 5 days.

Treatment in both arms continues through week 6 in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study within 18 months.

Conditions
Melanoma (Skin)
Being tested
MAGE-10.A2, MART-1 antigen, NY-ESO-1 peptide vaccine, sargramostim, tyrosinase peptide
Keywords
stage III melanoma, 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.

  • MAGE-10.A2Biological

  • MART-1 antigenBiological

  • NY-ESO-1 peptide vaccineBiological

  • sargramostimBiological

  • tyrosinase peptideBiological

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 startOct 2001

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
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00037037
Sponsor's protocol ID
CDR0000069357
Other IDs
CPMC-IRB-13824, LUDWIG-LUD00-025, NCI-G02-2068
Status last verified
May 2004
First submitted
13 May 2002
Last updated
18 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MAGE-10.A2, MART-1 antigen and NY-ESO-1 peptide vaccine in people with Melanoma (Skin), run by Herbert Irving Comprehensive 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?

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 Dec 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 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.

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?

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 18 Dec 2013.

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