Clinical trial · Interventional
Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma
NCT00003646CI-TRIAL-00005177completedPhase 2ClinicalTrials.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: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allovectin-7 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Minimum age
- 18 Years
Show eligibility criteria text
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Histologically confirmed melanoma; Stage III with locoregional disease, in transit metastasis, or nodal disease OR Stage IV metastatic disease in skin, subcutaneous tissue, lymph node(s), and/or lung * At least 1 metastasis for which surgery is not deemed to be a curative option * Relapsed from or has not responded to frontline chemotherapy or biotherapy * At least 1 measurable tumor at least 1 cm by 1 cm, but less than 5 cm by 5 cm * No history of brain metastases or visceral metastases other than lung metastases --Prior/Concurrent Therapy-- * Biologic therapy: See Disease Characteristics; At least 4 weeks since prior biologic therapy * Chemotherapy: See Disease Characteristics; At least 4 weeks since 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 any other experimental therapy --Patient Characteristics-- * Age: 18 and over * Performance status: Karnofsky 80-100% * Life expectancy: At least 6 months * 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; PT/PTT normal LDH and albumin normal * 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; 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 in 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.