Phase 2
Completed N=28
Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma
Melanoma (Skin)
Source: ClinicalTrials.gov NCT00101166 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Number of Participants With Partial Response — 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Partial Response |
1 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment |
— | — |
| SECONDARY Number of Participants With Stable Disease |
8 | — |
| SECONDARY Time to Progression (TTP) in Months |
3.8 | — |
| SECONDARY Overall Survival (OS) in Months |
12.8 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00101166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.