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Interleukin-7 and Vaccine Therapy in Treating Patients With Metastatic Melanoma
This study has been completed.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00091338
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Drug: MART-1 antigen
Drug: gp100 antigen
Drug: incomplete Freund's adjuvant
Drug: recombinant interleukin-7
Phase I

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Freund's adjuvant Montanide ISA 51
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091338

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Principal Investigator: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000387802, NCI-04-C-0235
Study First Received: September 7, 2004
Last Updated: December 13, 2008
ClinicalTrials.gov Identifier: NCT00091338  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Freund's Adjuvant
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Adjuvants, Immunologic
Nevi and Melanomas
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009