Clinical trial · Interventional
Metronomic Therapy in Patients With Metastatic Melanoma
Metronomic Therapy in Patients With Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual not allowing to support statistical endpoints
Summary
Brief summary (as posted)
SUMMARY: Metronomic Therapy in Patients with Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine. Patients with measurable metastatic melanoma are eligible. All patients will be treated as outlined below with combined vinblastine, cyclophosphamide, and dacarbazine. Patients will be treated continuously, until evidence of progression of disease, or for up to two cycles following disappearance of all disease. A cycle will be defined as three weeks of continuous therapy with a one week rest.
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 |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dacarbazine | Drug | Dacarbazine | ALIAS |
| vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined Low Dose Treatment
- description
- A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest. Schema of treatment is: 1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv
- interventionNames
- Drug: vinblastine
- Drug: Cyclophosphamide
- Drug: dacarbazine
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
- description
- Tumor evaluation will be performed every 8 weeks from day 1 of cycle 1 (+/- 1 week) while on therapy assessed by RECIST 1.0 criteria.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Metastatic melanoma with measurable disease * Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or chemotherapy (6 weeks for nitrosoureas) and recovered from all ill * Karnofsky Performance Status ≥60% * Life expectancy ≥ twelve weeks * Adequate end organ function * Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study. * Appropriate Contraception in both sexes * The patient must be competent and signed informed consent. EXCLUSION CRITERIA * Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence, breast CIS. * In patients with a prior history of invasive malignancy, less than five years in complete remission. * Have evidence of significant co-morbid illness such as uncontrolled diabetes - Uncontrolled brain metastasis: Patients with brain metastasis most have been treated with brain radiation therapy or surgery and remain clinically stable for a minimum of 4 weeks.
References
Publications (0)
Data not yet available