Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma
This study has been completed.
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborators:
American Society of Clinical Oncology
Society of Surgical Oncology (SSO)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00101166
First received: January 7, 2005
Last updated: November 16, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: Bystander-Based Autologous Tumor Cell Vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:
Primary Outcome Measures:
- Number of Participants With Partial Response [ Time Frame: Average of 14 months ] [ Designated as safety issue: No ]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 [ Time Frame: Average of 14 months ] [ Designated as safety issue: Yes ]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 [ Time Frame: Average of 14 months ] [ Designated as safety issue: No ]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 [ Time Frame: Average of 14 months ] [ Designated as safety issue: No ]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 [ Time Frame: Average of 14 months ] [ Designated as safety issue: No ]Average overall survival time in months.
| Enrollment: | 43 |
| Study Start Date: | October 2004 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vaccine Therapy
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.
|
Biological: Bystander-Based Autologous Tumor Cell Vaccine
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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101166
Locations
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
American Society of Clinical Oncology
Society of Surgical Oncology (SSO)
Investigators
| Principal Investigator: | Sophie Dessureault, M.D., Ph.D. | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00101166 History of Changes |
| Other Study ID Numbers: | MCC-13639, 0407-657 |
| Study First Received: | January 7, 2005 |
| Results First Received: | October 18, 2012 |
| Last Updated: | November 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
|
recurrent melanoma stage III melanoma stage IV melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 19, 2013