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Phase II Trial of Sequenced Chemotherapy With Dacarbazine and Carmustine With Neulasta® Support in Previously Treated Metastatic Melanoma


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

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Trial Information

Phase II Trial of Sequenced Chemotherapy With Dacarbazine and Carmustine With Neulasta® Support in Previously Treated Metastatic Melanoma


In this phase II trial, patients with stage IV melanoma will be treated with dacarbazine and
carmustine commonly used in this cancer, but given using a schedule that might theoretically
improve on this combination. Patients on this study will be assessed in terms of toxicity,
response rate, median duration of response, median time to disease progression, and median
survival.


Inclusion Criteria:



1. Patients must have a histologically-proven diagnosis of metastatic malignant melanoma
which has progressed on at least one prior systemic therapy.

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 and
estimated survival of at least 3 months.

3. Patients must be felt to have recovered from effects of prior cancer therapy, such as
past expected leukocyte nadir for chemotherapy (> 2 weeks).

4. Absolute granulocyte count of at least 1500/mm3; hemoglobin of at least 9 gm/dl;
platelet count of at least 100,000/mm3; bilirubin must be less than 1.5 mg/dl; ALT
and AST must be less than 3 times the upper limit of normal; creatinine must be less
than or equal to 1.8 mg/dl.

5. Women of childbearing potential must have a negative pregnancy test and adequate
precautions to prevent pregnancy during treatment must be taken.

6. Patient consent must be obtained prior to entrance onto study.

7. Patients must have no evidence of significant cardiovascular disease including
history of recent (< 6 months) myocardial infarction, uncompensated congestive heart
failure, uncontrolled angina or cerebrovascular accident.

Exclusion Criteria:

1. Evidence of significant cardiovascular disease including history of recent (< 6
months) myocardial infarction, uncompensated congestive heart failure, uncontrolled
angina, or cerebrovascular accident.

2. Prior history of psychiatric disorder that could be exacerbated by or which could
preclude completion of this therapy.

3. Pregnancy or lactation.

4. Prior chemotherapy with carmustine

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 of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Walter Quan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Western Regional Medical Center

Authority:

United States: Institutional Review Board

Study ID:

12-10

NCT ID:

NCT01692691

Start Date:

August 2012

Completion Date:

July 2013

Related Keywords:

  • Melanoma Metastatic
  • Melanoma Metastatic
  • Melanoma

Name

Location

Western Regional Medical CenterGoodyear, Arizona  85338