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

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bystander-Based Autologous Tumor Cell Vaccine
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage III melanoma, stage IV melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccine Therapy

Arm Description

Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.

Outcomes

Primary Outcome Measures

Number of Participants With Partial Response
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 Outcome Measures

Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment
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).
Number of Participants With Stable Disease
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.
Time to Progression (TTP) in 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.
Overall Survival (OS) in Months
Average overall survival time in months.

Full Information

First Posted
January 7, 2005
Last Updated
January 31, 2018
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI), American Society of Clinical Oncology, Society of Surgical Oncology (SSO)
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1. Study Identification

Unique Protocol Identification Number
NCT00101166
Brief Title
Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI), American Society of Clinical Oncology, Society of Surgical Oncology (SSO)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage III melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine Therapy
Arm Type
Experimental
Arm Description
Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.
Intervention Type
Biological
Intervention Name(s)
Bystander-Based Autologous Tumor Cell Vaccine
Other Intervention Name(s)
GM.CD40L, bystander cells, Melanoma Vaccine, Immunotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Partial Response
Description
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.
Time Frame
Average of 14 months
Secondary Outcome Measure Information:
Title
Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment
Description
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).
Time Frame
Average of 14 months
Title
Number of Participants With Stable Disease
Description
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.
Time Frame
Average of 14 months
Title
Time to Progression (TTP) in Months
Description
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.
Time Frame
Average of 14 months
Title
Overall Survival (OS) in Months
Description
Average overall survival time in months.
Time Frame
Average of 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Dessureault, M.D., Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States

12. IPD Sharing Statement

Links:
URL
https://moffitt.org/clinical-trials-research/
Description
Moffitt Cancer Center Clinical Trials website

Learn more about this trial

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

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