Could a Custom-Made vaccine beat advanced melanoma?
NCT ID NCT00626860
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new type of vaccine made by fusing a patient's own immune cells with their cancer cells. The goal was to see if it was safe and could help the immune system fight advanced melanoma. Twenty adults with spreading melanoma that was getting worse took part. The vaccine was designed to teach the body to attack the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Jul 2000
- Finished
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Sep 2008
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * patients with confirmed diagnoses of disseminated melanoma, with measurable and clearly progressive metastatic involevment * Patients must be at least 18 years old * Patients must have ECOG performance status 0-1 with greater than 9 week life expectancy * Those patients with the following accessible tumor will be eligible: soft tissue, bone marrow or visceral lesions; Skin or superficial soft tissue, or lymph nodes amenable to resection under local anesthesia; Patients who require surgical procedures that are not considered significantly invasive but may require general anesthesia, such as thorascopic biopsy, laparascopic biopsy or mediastinal node biopsy may potentially be eligible; Malignant ascites or pleural effusion; Patients requiring major surgical intervention will be considered ineligible. Patients scheduled to undergo tumor resection for independent diagnostic or therapeutic indications may have tumor collected for the purposes of this study. * Labs: WBC \>\_ 2.0 x 10x3/uL, Bilirubin \<\_2.0 mg/dL, Creatine \<\_ 2.0mg/dL * Women of childbearing age must have a negative pregnancy test and adequate contraception method(s) must be documented * All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines Exclusion Criteria: * Patients must not have received other immunotherapy treatment in the past four weeks prior to study entry * Patients must not have received chemotherapy for three weeks prior to the first vaccination * Patients must be without evidence of active CNS disease * Patients must not have clinically significant autoimmune disease * Patients must be HIV negative * Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure * Patients requiring corticosteroids for either melanoma related or co-morbid illness
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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BIDMC
Boston, Massachusetts, 02215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a DNA vaccine teach the immune system to hunt melanoma?
- Can an immune booster make chemo hit melanoma harder?
- A quest to find biomarkers that match melanoma patients with the right immunotherapy
- Can a triple immunotherapy attack beat advanced melanoma?