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Vaccine Therapy in Treating Patients With Melanoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Providence Cancer Center, Earle A. Chiles Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00052988
  Purpose

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.

PURPOSE: Phase I trial to study the effectiveness of booster vaccinations in preventing cancer recurrence in patients who have melanoma.


Condition Intervention Phase
Melanoma (Skin)
Drug: HPV 16 E7:12-20 peptide vaccine
Drug: gp100 antigen
Drug: incomplete Freund's adjuvant
Procedure: adjuvant therapy
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, Open Label
Official Title: A Pilot Study To Access The Immunologic Response To Booster Vaccination With A Modified gp100 Melanoma Peptide (209-2M) Vaccine In Previously Vaccinated HLA-A2.1+ Patients With Melanoma

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

Study Start Date: October 2002
Detailed Description:

OBJECTIVES:

  • Determine the toxicity of booster vaccination with gp100:209-217 (210M) peptide and HPV-16 E7 (12-20) peptide vaccine emulsified in Montanide ISA-51 administered at least 12 months after prior vaccination in patients with melanoma.
  • Determine T-cell response to modified gp100: 209-217 (210M) peptide and unmodified native gp100 peptide in these patients.
  • Determine T-cell response to the control HLA-A2-restricted CD8 epitope of HPV-16 E7 (12-20) peptide vaccine in these patients.

OUTLINE: Patients undergo leukapheresis on day 0. Patients receive vaccination comprising gp100:209-217 (210M) and HPV-16 E7 (12-20) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 and between days 25-30 in the absence of disease progression or unacceptable toxicity. Patients undergo a second leukapheresis 2-4 weeks after the second vaccination.

Patients who remain disease free for 6 months after the second vaccination may receive additional booster vaccinations SC every 6 months for 3 years.

Patients are followed at 3 and 6 months after the second vaccination and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1.5 years.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Completed treatment on PPMC-IRB-99-9*

    • At least 12 months since last vaccination NOTE: *Patients are not required to have received every planned vaccine as long as the reason for stopping was not disease progression or dose-limiting toxicity
  • No current evidence of melanoma, as defined by one of the following:

    • Disease-free since completion of PPMC-IRB-99-9
    • Recurrence occurred but was completely resected

PATIENT CHARACTERISTICS:

Age

  • Over 16

Performance status

  • Karnofsky 80-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic

  • Bilirubin no greater than 2 mg/dL

Renal

  • Creatinine no greater than 2 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after study participation
  • No other concurrent medical or psychiatric illness that would preclude study participation
  • No concurrent significant systemic infection
  • No other concurrent cancer or at low risk for recurrence of prior cancers

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • Not specified

Endocrine therapy

  • No concurrent systemic corticosteroids for intercurrent illness

Radiotherapy

  • Not specified

Surgery

  • Recovered from prior major surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052988

Locations
United States, Oregon
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Sponsors and Collaborators
Providence Cancer Center, Earle A. Chiles Research Institute
Investigators
Study Chair: Walter J. Urba, MD, PhD Providence Cancer Center, Earle A. Chiles Research Institute
  More Information

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

Study ID Numbers: CDR0000258479, PPMC-IRB-02-63, NCI-5925
Study First Received: January 27, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00052988  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I melanoma
stage II melanoma
stage III melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Freund's Adjuvant
Nevus
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 16, 2009