Clinical trial · Interventional
Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma
Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF, IFN-a2b, and IL-2 in Patients With Advanced Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining more than one drug with different types of biological therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus biological therapy in treating patients who have metastatic melanoma.
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 (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| dacarbazine | Drug | Dacarbazine | ALIAS |
| Granulocyte-macrophage colony-stimulating factor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- CDDP (75 mg/m2) and DTIC (660 mg/m2) will be administered sequentially by intravenous infusion in day 1. Subsequently, GM-CSF (450 mg/ m2) will be administered SC days 2-7; IL-2 (11 MU daily) will be given SC days 8-14, and IFN-2b (9 MU) will be given SC days 8, 10, 12, and 14.
- interventionNames
- Drug: Cisplatin
- Drug: dacarbazine
- Drug: Granulocyte-macrophage colony-stimulating factor
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma * Stage III with intransit metastases * Stage IV * No uncontrolled brain metastases by CT scan * No clinically significant ascites or pleural effusions PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Karnofsky 70-100% Life expectancy: * At least 10 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.5 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT no greater than 4 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 70 mL/min Cardiovascular: * No clinically significant cardiac disease on EKG, echocardiogram, or MUGA scan Pulmonary: * No clinically significant pulmonary disease on chest x-ray Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No significant thyroid dysfunction * No concurrent severe infection * No other medical or psychiatric condition that would interfere with compliance * No second malignancy within the past 5 years, except: * Localized nonmelanomatous skin cancer * Carcinoma in situ of the cervix * Grade 1 Ta bladder cancer * Suspected hearing deficits must undergo audiologic testing PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than one prior immunotherapy regimen * At least 4 weeks since prior immunotherapy * Adjuvant interferon alfa before relapse allowed Chemotherapy: * No more than one prior chemotherapy regimen * At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) * No concurrent cyclophosphamide * No other concurrent chemotherapy Endocrine therapy: * No concurrent corticosteroids or cyclosporine A Radiotherapy: * At least 2 weeks since prior radiotherapy Surgery: * At least 3 weeks since major surgery Other: * No concurrent immunosuppressive drugs * No other concurrent investigational antineoplastic drugs * Concurrent thyroid replacement therapy allowed
References
Publications (0)
Data not yet available