Completed

A Pilot Trial of Therapeutic Vaccination With a Modified gp100 Melanoma Peptide (gp100:209-217(210M)), Montanide ISA 51, and KLH With Reconstitution After Chemotherapy to Induce Lymphopenia in Patients With Metastatic Melanoma

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What is being tested

Data Collection

Who is being recruted

Melanoma+8

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2004
See protocol details

Summary

Principal SponsorProvidence Cancer Center, Earle A. Chiles Research Institute
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the toxicity and immune effects of vaccination comprising modified gp100 peptide (gp100:209-217\[210M\]), Montanide ISA-51, and keyhole limpet hemocyanin followed by peripheral blood mononuclear cell reinfusion after treatment-induced lymphopenia with fludarabine in patients with unresectable or metastatic melanoma. * Determine the induction of antigen-specific T-cell responses in patients treated with this regimen. * Determine the kinetics and duration of immune response in patients treated with this regimen. * Compare the immunologic effects of this regimen in these patients with historical results. Secondary * Compare 2 different dosing schedules of fludarabine, in terms of induction of lymphopenia and granulocytopenia and on the induction of a specific immune response to this vaccine, in these patients. OUTLINE: This is a pilot, randomized study. Patients are randomized to 1 of 2 treatment arms. Within 2 weeks before the start of fludarabine, all patients undergo leukapheresis over 4-6 hours for the collection of peripheral blood mononuclear cells (PBMCs). * Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5. * Arm II: Patients receive fludarabine as in arm I on days 1, 3, and 5. In both arms, patients receive autologous PBMCs IV over approximately 30 minutes on day 8 and vaccination comprising gp100:209-217(210M) peptide, Montanide ISA-51, and keyhole limpet hemocyanin subcutaneously on days 8, 22, 36, 50, and 64. Patients with stable or responding disease continue to receive vaccination on day 78 and then every 28-31 days for up to 1 year. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study within 2 years.

Official TitleA Pilot Trial of Therapeutic Vaccination With a Modified gp100 Melanoma Peptide (gp100:209-217(210M)), Montanide ISA 51, and KLH With Reconstitution After Chemotherapy to Induce Lymphopenia in Patients With Metastatic Melanoma 
NCT00091143
Principal SponsorProvidence Cancer Center, Earle A. Chiles Research Institute
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

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

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

Criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant melanoma * Metastatic or unresectable disease * Measurable disease * HLA-A2 positive * Received at least 1 prior immunotherapy and/or chemotherapy regimen for metastatic disease (first 6 patients only) * No known brain metastases unless previously treated with radiotherapy and/or surgery AND is stable for at least 1 month after treatment PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Absolute lymphocyte count ≥ 500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL (transfusions allowed) * Hematocrit ≥ 24% * No other active bleeding Hepatic * Bilirubin \< 2 times upper limit of normal (ULN) (unless due to Gilbert's disease) * AST and ALT \< 3 times ULN * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine \< 2 mg/dL * No uncontrolled hypercalcemia Cardiovascular * No uncontrolled symptomatic congestive heart failure * No unstable angina pectoris * No uncontrolled cardiac arrhythmia * No uncontrolled hypertension Pulmonary * No uncontrolled bronchospasm * No hemoptysis Immunologic * Negative serology for all of the following: * HIV-1 and HIV-2 * HTLV-1 and -2 * Syphilis * Rheumatoid factor \< 43 units/μL * Anti-nuclear antibody \< 11 units/μL * No history of multiple sclerosis, systemic lupus erythematosus, or myasthenia gravis * No primary or secondary immunodeficiency * No active infection * No allergy to seafood or shellfish that would preclude study participation Other * No active gastrointestinal bleeding * No uncontrolled hyperglycemia * No other medical or psychiatric condition or social situation that would preclude study compliance * No other uncontrolled illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3-4 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior immunization with gp100:209-217(210M) peptide Chemotherapy * See Disease Characteristics * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy * More than 2 weeks since prior steroid therapy except replacement steroids or inhaled steroids * No concurrent corticosteroids except replacement steroids * No concurrent dexamethasone Radiotherapy * See Disease Characteristics * More than 2 weeks since prior radiotherapy Surgery * See Disease Characteristics * Recovered from prior surgery Other * No other concurrent investigational agents * No other concurrent anticancer therapy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Providence Cancer Center at Providence Portland Medical Center

Portland, United StatesSee the location
CompletedOne Study Center