Clinical trial · Interventional
Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma
Phase II, Open-Label Trial in Patients With Stage IV Malignant Melanoma Using Melaxin as a Cancer Vaccine in Conjunction With BCG
NCT00671554CI-TRIAL-00014781terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to business considerations; not due to toxicities or adverse events.
Summary
Brief summary (as posted)
The purpose of this study is to determine if treatment with the autologous cellular vaccine, Melaxin, in combination with Bacillus Calmette-Guerin (BCG) injections is effective in Stage IV malignant melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melaxin (autologous dendritoma vaccine) and BCG | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Melaxin and BCG
- description
- Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration
- interventionNames
- Biological: Melaxin (autologous dendritoma vaccine) and BCG
Primary outcomes (1)
- measure
- Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results.
- timeFrame
- From first vaccine to 18 months after the last injection
- description
- Expected adverse events included injection site reactions, fever, chills, and arthralgias as anticipated with vaccine therapy. No unexpected or uncommon adverse events occurred such as disseminated sepsis. Clinical laboratory results on all participants were within expected ranges, including an increase in the number of IFN gamma expressing T-cells.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to give informed consent * Male or female patient whose age is \> 18 years of age * Histological documented Stage IV malignant melanoma (American Joint Committee on Cancer (AJCC) sixth edition) * Pathology report from tumor specimen verifying melanoma diagnosis * Free of infection * Hemoglobin\> 9.0 grams per deciliter (gm/dL), White Blood Cells (WBC) \>3000/ cubic millimeters (mm3), platelets\> 100,000mm3 * Liver function test that are less than 2 times the upper limit of normal of the reference range for the testing laboratory * Adequate cardiac function-any evidence of ischemic heart disease demonstrated by history, physical, or EKG will require referral to a cardiologist for evaluation and clearance prior to protocol therapy * No immunotherapy within the past 3 months * A minimum of 4 doses of lot-released, autologus Melaxin (1.0 million dendritomas) Exclusion Criteria: * Other malignancies in the past 5 years with the exception of non-melanoma skin cancer or carcinoma in situ of the cervix * Has received any immunosuppressive agent within 30 days prior to treat * Creatinine\> 2.5 milligrams per deciliter (mg/dL) or currently on dialysis * Positive serum pregnancy test, breast-feeding,or planning to conceive or father or father a child in the period surrounding the study as described in the informed consent. * Women of childbearing potential who cannot follow the directions for birth control * Eastern Cooperative Oncology Group (ECOG) performance status greater than 3 * Positive Rdonr panel (Human Immunodeficiency virus (HIV) 1, 2; Human T-lymphotropic virus (HTLV-1,2); Hepatitis B and C) * History of a seizure disorder * Brain metastases that have progressed within the last 6 months * No measurable disease
References
Publications (0)
Data not yet available
No reference posted for this study.