Completed

En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma

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What is being tested

Data Collection

Who is being recruted

Melanoma+9

+ Neoplasms

+ Neoplasms by Histologic Type

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

Treatment Study

Phase 1
Interventional
Study Start: February 2004
See protocol details

Summary

Principal SponsorDartmouth-Hitchcock Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the dose-limiting toxicity and the maximum tolerated dose of autologous dendritic cells pulsed with autologous tumor cell lysate in patients with stage III or IV melanoma. * Determine the safety and tolerability of this therapy in these patients. Secondary * Determine the immune response, in terms of the type and degree of T-cell proliferation and delayed-type hypersensitivity responses, in patients treated with this therapy. OUTLINE: This is a dose-escalation, pilot study. Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC) on days -9, 19, and 47. Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF), interleukin-4, and tumor necrosis factor alpha and pulsed with autologous tumor cell lysate. Patients receive autologous tumor cell lysate-pulsed DC IV over 5-10 minutes on days 0, 28, and 56. Cohorts of 3-6 patients receive escalating doses of autologous tumor cell lysate-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of all patients experience dose-limiting toxicity. Patients are followed at day 84 and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 3-20 months.

Official TitleEn Vivo Matured Dendritic Cell Therapy in Patients With Melanoma
NCT00085488
Principal SponsorDartmouth-Hitchcock Medical Center
Last updated: January 27, 2026
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.

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 NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed melanoma * Stage III (lymph node or in-transit metastases) or IV (systemic metastases) disease * Patients with relapsed disease OR who failed prior immunotherapy or chemotherapy are eligible (but trial not restricted to relapsed or refractory disease) * Tumor tissue available and properly stored for lysate preparation PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 Hepatic * AST ≤ 2 times upper limit of normal (ULN) (3 times ULN for liver metastases) * Bilirubin ≤ 2 times ULN * Hepatitis B surface antigen negative * Hepatitis C negative Renal * Creatinine ≤ 2.0 times ULN Immunologic * No active infection * No history of autoimmune disease, including any of the following: * Inflammatory bowel disease * Systemic lupus erythematosus * Scleroderma * Rheumatoid arthritis * Multiple sclerosis * No allergy to aminoglycosides or streptomycin * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No significant comorbid illness * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 10 days since prior immunotherapy Chemotherapy * See Disease Characteristics Endocrine therapy * At least 6 weeks since prior steroid therapy * No concurrent corticosteroids Radiotherapy * At least 10 days since prior radiotherapy * No concurrent radiotherapy Surgery * At least 10 days since prior surgery * Prior diagnostic or palliative surgery allowed provided the patient has fully recovered Other * No concurrent immunosuppressive or potentially immunosuppressive 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

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

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, United StatesOpen Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center in Google Maps
CompletedOne Study Center