Clinical trial · Interventional
A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment With 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects With Recurrent Metastatic Melanoma
NCT00395070CI-TRIAL-00012064completedPhase 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)
To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 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 |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allovectin-7® | Biological | — | UNRESOLVED |
| Dacarbazine (DTIC) | Drug | Dacarbazine | ALIAS |
| Temozolomide (TMZ) | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
- interventionNames
- Biological: Allovectin-7®
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- description
- DTIC 1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR TMZ 150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.
- interventionNames
- Drug: Dacarbazine (DTIC)
- Drug: Temozolomide (TMZ)
Primary outcomes (1)
- measure
- To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (Potential study participants must meet the following criteria): * Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2) * At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected * Normal blood chemistries and blood cell counts * At least 18 years old and able and willing to provide informed consent to participate Exclusion Criteria (Potential study participants will not be eligible with the following): * Previous chemotherapy treatment for melanoma * Melanoma lesions in the brain or liver (however, lesions in the lungs are allowed) * If surgical removal of all lesions would be possible and could be curative * Any melanoma tumors greater than 10cm x 10cm in size * Known condition resulting in a suppressed immune system * Female subjects who are pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.