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

April 29, 2015 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Registration Dates

First Submitted

September 7, 2004

First Submitted That Met QC Criteria

September 8, 2004

First Posted (ESTIMATE)

September 9, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

January 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000387802
  • NCI-04-C-0235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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