Ensayo clínico en fase 3 para evaluar la seguridad y la eficacia del tratamiento con 2 mg de Allovectin-7® intralesional comparado con dacarbazina (DTIC) o temozolomida (TMZ) en pacientes con melanoma recurrente metastásico - Allovectin-7® Immunotherapy for Metastatic Melanoma (A.I.M.M)

• Conditions: Recurrent metastatic melanoma; MedDRA version: 9.1Level: LLTClassification code 10027481Term: Metastatic melanoma

• Registration Number: EUCTR2007-004120-21-ES
• Lead Sponsor: Vical Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

- Able and willing to provide informed consent and sign the informed consent form
- Age 18 or more years
- ECOG performance status of 0 or 1
- Histologically confirmed recurrent metastatic melanoma, which may have received primary surgical resection, adjuvant therapy, and/or biotherapy
- At least one injectable lesion (cutaneous, subcutaneous, or nodal lesion) =1 cm2 and =25 cm2. Lesions between 25 cm2 and 100 cm2 are not injected but may be followed as target lesions
- LDH within normal limits
- Serum creatinine = 2.0 mg/dL
- Platelet count 100,000/mm3 or more
- White blood cell count 2500/mm3 or more
- Male and female subjects of child bearing potential must agree to use an effective method of contraception
- Negative pregnancy test for women of child bearing potential
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Prior cytotoxic chemotherapy for malignant melanoma
- Prior Allovectin-7® injection(s)
- Any lesion 100 cm2 or more
- History of visceral metastasis, M1c, other than lung (M1b not excluded)
- Surgery as a curative option
- Radiation therapy, immunosuppressive therapy or biologic therapy within four weeks prior to trial entry
- Major surgery within two weeks prior to trial entry
- Known positive HIV serology
- Other malignancy not currently in remission or unlikely to have been cured with prior therapy (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or low grade prostate cancer)
- Concurrent immunosuppressive therapy, anticancer therapy or investigational treatment
- Active autoimmune disease requiring immunosuppressive or other therapies; e.g. Hashimoto’s Disease, Systemic Lupus Erythematosus, autoimmune hepatitis, Wegner’s granulomatosis, etc.
- Significant psychiatric disorders that would make compliance with the protocol difficult or would compromise ability to give informed consent
- Female subjects who are pregnant or lactating

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy and safety of treatment with Allovectin-7® versus treatment with DTIC or TMZ in subjects with recurrent metastatic melanoma. ;Secondary Objective: To compare the safety/tolerability of treatment with Allovectin-7® versus treatment with DTIC or TMZ in subjects with recurrent metastatic melanoma. ;Primary end point(s): To compare the overall response rate at =24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm.