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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00091338
First received: September 7, 2004
Last updated: February 6, 2009
Last verified: January 2005
  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)
Biological: MART-1 antigen
Biological: gp100 antigen
Biological: incomplete Freund's adjuvant
Biological: recombinant interleukin-7
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00091338     History of Changes
Obsolete Identifiers: NCT00088322
Other Study ID Numbers: CDR0000387802, NCI-04-C-0235
Study First Received: September 7, 2004
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014