Dacarbazine and Carmustine in Metastatic Melanoma

NCT ID: NCT01692691

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-10-31

Brief Summary

The purpose of this study is to determine whether dacarbazine and carmustine at the doses and schedule used in this study will help to increase tumor shrinkage.

Detailed Description

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.

Conditions

Melanoma Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dacarbazine, carmustine, neulasta

Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3

Group Type: EXPERIMENTAL

Dacarbazine

Intervention Type: DRUG

Dacarbazine IV - Day 1

Carmustine

Intervention Type: DRUG

Carmustine IV- Day 2

Neulasta

Intervention Type: DRUG

Neulasta SC - Day 3

Interventions

Dacarbazine

Dacarbazine IV - Day 1

Intervention Type: DRUG

Carmustine

Carmustine IV- Day 2

Intervention Type: DRUG

Neulasta

Neulasta SC - Day 3

Intervention Type: DRUG

Other Intervention Names

DTIC; BCNU; pegfilgrastim

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordan Waypa, FNP

Role: STUDY_DIRECTOR

CTCA

Locations

Western Regional Medical Center

Goodyear, Arizona, United States

Countries

United States

Other Identifiers

12-10

Identifier Type: -

Identifier Source: org_study_id