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Melanoma (Skin)Phase 1NCT00091338

Interleukin-7 and Vaccine Therapy in Treating Patients With Metastatic Melanoma

A Phase 1 study testing MART-1 antigen, gp100 antigen and incomplete Freund's adjuvant in people with Melanoma (Skin), run by National Cancer Institute (NCI) 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: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Combining interleukin-7 with vaccine therapy 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?
MART-1 antigen, gp100 antigen and incomplete Freund's adjuvant
How many people
Not given
Where
1 siteUnited States
Study dates
Aug 2004to 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 melanoma
  • Metastatic disease
  • Measurable or evaluable disease
  • Disease progression during or after prior interleukin-2 (IL-2) OR ineligible to receive high-dose IL-2* OR has disease burden for which IL-2 is not indicated* NOTE: *If patient did not receive prior IL-2, must have progressed after prior standard first-line therapy (e.g., metastasectomy for single lesions or dacarbazine)
  • HLA-A*0201-positive disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Absolute neutrophil count > 1,000/mm^3*
  • Absolute lymphocyte count ≥ 200/mm^3*
  • Platelet count > 100,000/mm^3
  • No proliferative hematologic disease NOTE: *For 2 consecutive readings performed on 2 different days

Hepatic

  • AST and ALT < 3 times upper limit of normal (ULN)
  • PT/PTT ≤ 1.5 times ULN
  • Hepatitis B negative
  • Positive hepatitis B serology indicative of prior immunization (i.e., positive for antibody against hepatitis B surface antigen AND negative for antibody against hepatitis B core antigen) allowed
  • Hepatitis C negative

Renal

  • Creatinine ≤ 1.4 mg/dL

Cardiovascular

  • Ejection fraction > 45% by MUGA for patients ≥ 50 years of age OR with a history of cardiac disease
  • No resting blood pressure > 140/90 mm Hg with standard antihypertensive therapy

Pulmonary

  • DLCO/VA and FEV_1 > 50% of predicted on pulmonary function test for smokers OR for patients with clinical evidence of compromised pulmonary function
  • No history of severe asthma

Immunologic

  • HIV negative
  • No history of autoimmune disease
  • No splenomegaly

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other medical or psychiatric disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • More than 4 weeks since prior cytokines
  • No prior allogeneic hematopoietic stem cell transplantation
  • No concurrent growth factors
  • No concurrent monoclonal antibodies
  • No other concurrent immunotherapy
  • No other concurrent cytokines
  • No other concurrent biologic agents

Chemotherapy

  • See Disease Characteristics
  • No prior intensive myeloablative chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • More than 2 weeks since prior systemic corticosteroids for more than 72 hours in duration
  • No concurrent systemic steroids

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
  • No prior splenectomy
  • No prior solid organ transplantation

Other

  • More than 4 weeks since prior cytotoxic therapy
  • No other concurrent cytotoxic therapy
  • No concurrent chronic anticoagulation therapy (e.g., high-dose warfarin, heparin, or aspirin)
  • Concurrent low-dose warfarin (1-2 mg) allowed
  • No concurrent chronic medication for asthma
  • No concurrent immunosuppressive therapy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

Official title: A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma

RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Combining interleukin-7 with vaccine therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 when given with vaccine therapy in treating patients with metastatic melanoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of interleukin-7 (IL-7) when administered with melanoma peptide vaccine emulsified in Montanide ISA-51 in patients with metastatic melanoma.
  • Determine the safety of this regimen in these patients.

Secondary

  • Determine the biological effects of this regimen on T-cell function and phenotype at various doses and at the optimal biological dose in these patients.
  • Determine the pharmacokinetic and pharmacodynamic characteristics of IL-7 in patients treated with this regimen.
  • Determine the antitumor effects of IL-7, in terms of a dose-escalation strategy, in these patients.

OUTLINE: This is a dose-escalation study of interleukin-7 (IL-7).

Patients receive IL-7 subcutaneously (SC) on days 0, 3, 6, 9, 12, 15, 18, and 21. Patients also receive melanoma peptide vaccine comprising gp100 antigen and MART-1 antigen emulsified in Montanide ISA-51 SC on days 0, 7, 14, and 21 in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of IL-7 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After the MTD is determined, an additional 13 patients are treated at that dose level.

Patients are followed at 1, 2, and 5 weeks, at 3 and 6 months, and then at 1 year.

PROJECTED ACCRUAL: A total of 3-37 patients will be accrued for this study within 1-12.3 months.

Conditions
Melanoma (Skin)
Being tested
MART-1 antigen, gp100 antigen, incomplete Freund's adjuvant, recombinant interleukin-7
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.

  • MART-1 antigenBiological

  • gp100 antigenBiological

  • incomplete Freund's adjuvantBiological

  • recombinant interleukin-7Biological

Timeline

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

  1. First posted9 Sep 2004 (estimated)
  2. Study startAug 2004

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00091338
Sponsor's protocol ID
CDR0000387802
Other IDs
NCI-04-C-0235
Status last verified
Jan 2005
First submitted
7 Sep 2004
Last updated
30 Apr 2015
Results posted
No

Publications

  • Rosenberg SA, Sportes C, Ahmadzadeh M, Fry TJ, Ngo LT, Schwarz SL, Stetler-Stevenson M, Morton KE, Mavroukakis SA, Morre M, Buffet R, Mackall CL, Gress RE. IL-7 administration to humans leads to expansion of CD8+ and CD4+ cells but a relative decrease of CD4+ T-regulatory cells. J Immunother. 2006 May-Jun;29(3):313-9. doi: 10.1097/01.cji.0000210386.55951.c2.

    PubMed 16699374

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MART-1 antigen, gp100 antigen and incomplete Freund's adjuvant in people with Melanoma (Skin), 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?

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 30 Apr 2015. 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?

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?

On the ClinicalTrials.gov record for NCT00091338, 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 30 Apr 2015.

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