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Completed

NCT Number: NCT00101166

Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma

The purpose of this study is to find out what effects (good and/or bad) this new cancer vaccine has on the patient and their cancer, whether it is safe and whether it can help get rid of their cancer (malignant melanoma). We want to check how the patient's immune system reacts, both before and after the vaccine treatment.

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Key information

Conditions

Melanoma (Skin) Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

About this study

The vaccine will be made by mixing two kinds of cells: 1) some of the patient's own malignant melanoma cells which were removed by surgery and then processed in the Cell Therapy Laboratory, and 2) experimental "bystander" cells. All the cells in the vaccine will be treated with high-dose X-rays to make sure that none of them grow and cause more cancer. The bystander cells, called "GM.CD40L", are human cells that have been genetically changed. The original cells, called K562, had the genes for human GM-CSF and CD40L inserted into them. These changes are designed to help boost the patient's immune system to better fight the cancer in their body.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed stage IIIC or stage IV melanoma
  • Measurable disease
  • Age 18 or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • No radiation therapy within 2 weeks prior to first vaccine administration
  • No chemotherapy within 4 weeks prior to first vaccine administration
  • No steroid therapy within 4 weeks prior to first vaccine administration
  • No surgery within 10 days prior to first vaccine administration
  • Patient's written informed consent
  • Patient's ability to comply with the visit schedule and assessments required by the protocol
  • Adequate organ function (measured within a week of beginning treatment):
  • White blood count (WBC) > 3,000/mm^3 and absolute neutrophil count (ANC) >1500/mm^3
  • Platelets > 100,000/mm^3
  • Hematocrit > 25% and Hgb > 8 g/dL
  • Bilirubin < 2.0 mg/dL
  • Creatinine < 2.0 mg/dL, or creatinine clearance > 60 mL/min

Exclusion criteria

  • Symptomatic or untreated brain metastasis
  • Any serious ongoing infection
  • Current corticosteroid or other immunosuppressive therapy
  • Any other pre-existing immunodeficiency condition (including known HIV infection)
  • Pregnant or lactating women -- Patients in reproductive age must agree to use contraceptive methods for the duration of the study (*A pregnancy test will be obtained before treatment)
  • ECOG performance status of 2, 3, or 4
  • Any second active primary cancer

Treatment and study plan

Bystander-Based Autologous Tumor Cell Vaccine

Biological

The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.

Other names: GM.CD40L, bystander cells, Melanoma Vaccine, Immunotherapy

Primary outcomes

  1. Number of Participants With Partial Response

    Time frame: Average of 14 months

    Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Secondary outcomes

  1. Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment

    Time frame: Average of 14 months

    Frequency of Study Related Toxicity. To evaluate the toxicity of the autologous tumor cell / GM.CD40L bystander cell vaccine. Toxicity was scored using the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE-3).

  2. Number of Participants With Stable Disease

    Time frame: Average of 14 months

    Patients with stable disease by RECIST criteria after 3 vaccine injections. Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

  3. Time to Progression (TTP) in Months

    Time frame: Average of 14 months

    Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  4. Overall Survival (OS) in Months

    Time frame: Average of 14 months

    Average overall survival time in months.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • American Society of Clinical Oncology
  • National Cancer Institute (NCI)
  • Society of Surgical Oncology (SSO)

Registry information

Official study title

A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Malignant Melanoma

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jan 10, 2005
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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