Clinical trial · Interventional
Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma
NCT00003647CI-TRIAL-00001620completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allovectin-7 | Drug | — | UNRESOLVED |
| allovectin-7/dacarbazine | Drug | — | UNRESOLVED |
| dacarbazine | Drug | Dacarbazine | ALIAS |
Eligibility
Eligibility (as posted)
- Minimum age
- 18 Years
Show eligibility criteria text
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Histologically confirmed stage III or IV melanoma 1 or more metastatic tumors for which surgery is not deemed to be a curative option * Dacarbazine is indicated as first line chemotherapy * At least 1 measurable tumor at least 1 cm2 but no greater than 100 cm2 * No history of brain metastases --Prior/Concurrent Therapy-- * Biologic therapy: At least 4 weeks since prior biologic therapy * Chemotherapy: See Disease Characteristics; No prior chemotherapy * Endocrine therapy: No concurrent immunosuppressive drugs * Radiotherapy: At least 4 weeks since prior radiotherapy * Surgery: At least 2 weeks since prior major surgery * Other: No other concurrent anticancer drug therapy or experimental therapy --Patient Characteristics-- * Age: 18 and over * Performance status: Karnofsky 80-100% * Life expectancy: At least 24 weeks * Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL * Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal (ULN); PT/PTT normal; Albumin normal; LDH no greater than 2 times ULN * Renal: Creatinine no greater than 2.0 mg/dL * Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease * Other: HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy within the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders
References
Publications (0)
Data not yet available
No reference posted for this study.