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Vaccine Therapy in Treating Patients With Melanoma - Article


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Vaccine Research


Clinical Trial: Vaccine Therapy in Treating Patients With Melanoma

This study is no longer recruiting patients.

Sponsors and Collaborators: Earle A. Chiles Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
stage I melanoma
stage II melanoma
stage III melanoma
 Drug: HPV-16 E7(12-20) peptide vaccine
 Drug: Montanide ISA-51
 Drug: gp100 antigen
 Procedure: adjuvant therapy
 Procedure: biological response modifier therapy
 Procedure: recombinant viral vaccine
 Procedure: vaccine therapy
Phase I

MedlinePlus related topics:  Melanoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Pilot Study of Booster Vaccination With gp100:209-217 (210M) Peptide and HPV-16 E7 (12-20) Peptide Vaccine Emulsified in Montanide ISA-51 in Previously Vaccinated Patients With Melanoma

Further Study Details: 

OBJECTIVES:

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 days 1 and 28 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 above,  Genders Eligible for Study:  Both

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

  • Concurrent systemic corticosteroids allowed provided they do not interfere with protocol therapy, in the opinion of the principal investigator

Radiotherapy

  • Not specified

Surgery

  • Recovered from prior major surgery

Location Information


Oregon
      Earle A. Chiles Research Institute at Providence Portland Medical Center, Portland,  Oregon,  97213-2967,  United States

Study chairs or principal investigators

Walter John Urba, PhD, MD,  Study Chair,  Earle A. Chiles Research Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000258479; PPMC-IRB-02-63; NCI-5925
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  January 27, 2003
ClinicalTrials.gov Identifier:  NCT00052988
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 13, 2008



Page Updated: September 20, 2004
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