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Metronomic Therapy in Patients With Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Melanoma

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Trial Information

Metronomic Therapy in Patients With Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine


Low dose continuous chemotherapy, called metronomic chemotherapy, is designed to target
vascular cells and inhibit tumor growth and metastasises. A recent study in a melanoma mouse
model has identified low dose vinblastine, cyclophosphamide and dacarbazine as a treatment
which improves the animal's survival and is superior to full dose dacarbazine alone. This
clinical trial seeks to translate this laboratory model directly into metastatic melanoma
patients.

Inclusion Criteria


- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

Tumor evaluation will be performed every 8 weeks from day 1 of cycle 1 (+/- 1 week) while on therapy.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Marc S. Ernstoff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center

Authority:

United States: Institutional Review Board

Study ID:

D1010

NCT ID:

NCT01542255

Start Date:

June 2010

Completion Date:

June 2014

Related Keywords:

  • Metastatic Melanoma
  • Metronomic Therapy
  • Metastatic Melanoma
  • Vinblastine
  • Cyclophosphamide
  • Dacarbazine
  • Melanoma

Name

Location
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756