Clinical trial · Interventional
Dacarbazine and Carmustine in Metastatic Melanoma
Phase II Trial of Sequenced Chemotherapy With Dacarbazine and Carmustine With Neulasta® Support in Previously Treated Metastatic Melanoma
NCT01692691CI-TRIAL-00032343terminatedPhase 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): PI decision
Summary
Brief summary (as posted)
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.
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 Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carmustine | Drug | Carmustine | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Neulasta | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dacarbazine, carmustine, neulasta
- description
- Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3
- interventionNames
- Drug: Dacarbazine
- Drug: Carmustine
- Drug: Neulasta
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 8 weeks
- description
- Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy
Secondary outcomes (2)
- measure
- Response Rate
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.