Status:
COMPLETED
A Study of Intratumoral CAVATAK™ in Patients With Stage IIIc and Stage IV Malignant Melanoma (VLA-007 CALM )
Lead Sponsor:
Viralytics
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the clinical efficacy of Intratumoral (IT) CVA21 in terms of immune-related Progression-Free Survival (irPFS) at 6 months as monitored via immune-related Respons...
Detailed Description
This is a multicenter, open-label, 2-stage, single-arm efficacy and safety study. Approximately 63 patients with histologically proven stage IIIc or stage IV melanoma who fail to qualify for curative ...
Eligibility Criteria
Inclusion
- Patient with histologically proven stage IIIc or stage IV melanoma who fails to qualify for curative surgery and who bears one or more tumors that are accessible for direct injection
- Patient must have had no more than one previous systemic regimen for management of melanoma; however, adjuvant chemotherapy administered 6 months or longer before entering the trial does not count as a line of treatment
- Absence of circulating serum neutralizing antibodies to CVA21 (titer \< 1:16)
- At least one tumor 0.5 to 10 cm in the longest diameter must be suitable for injection and at least one tumor must be equal to or greater than 1 cm and qualified to be a target lesion for RECIST 1.1 criteria
- Patient must have adequate hematologic, hepatic and renal function, defined as:
- Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L
- Bilirubin \< 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) \< 2.5 x ULN
- Serum creatinine \< 1.5 x ULN; if \> 1.5 x ULN, it must be confirmed that creatinine clearance \> 30 mL/minute
- Serum lactate dehydrogenase (LDH) levels \< or = 1.5 x ULN
- Male or female age 18 years or older
- Performance status (Eastern Cooperative Oncology Group \[ECOG\]) 0 or 1
- Estimated life expectancy of more than 6 months
- Recovered from prior therapy with at least 4 weeks since the last exposure to chemotherapy or radiotherapy
- Patient is able and willing to provide written informed consent to participate in the study
- Fertile males and females must agree to the use of an adequate form of contraception, e.g., condoms for males. A negative pregnancy test is required in female patients of childbearing potential.
Exclusion
- Mucosal or ocular primary tumors
- Bone metastases
- Greater than 3 visceral metastases
- Any visceral metastases \> 10 cm
- Serum anti-CVA21 neutralizing titer of \> 1:16 at baseline
- Presence of any central nervous system (CNS) tumor that has not been stable for at least 3 months off corticosteroids and confirmed by imaging
- Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion into a major vessel in the case of necrosis
- Only measurable tumor had prior local radiotherapy without subsequent nodule progression
- Patient has received chemotherapy within the last 4 weeks prior to first injection
- ECOG score greater than 1
- Estimated life expectancy of less than 6 months
- Pregnancy or breastfeeding
- Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g., prednisolone \> 7.5 mg per day) or other immunosuppressive medications including cyclosporine, azathioprine, interferons within the past 4 weeks prior to screening
- Positive serology for human immunodeficiency virus (HIV), hepatitis B or C
- Full dose anticoagulation or a history of bleeding diathesis or poorly controlled bleeding in the last month prior to screening
- Previous splenectomy
- Presence of uncontrolled infection
- Presence of unstable neurological disease
- Any uncontrolled medical condition that, in the opinion of the investigator, is likely to place the patient at unacceptable risk during the study or reduce his/her ability to complete the study
- Participation in another study requiring administration of an investigational drug or biological agent within the last 4 weeks prior to screening
- Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
- Participation in any previous melanoma immunotherapy trial within 1 month prior to entry to this trial or any trial of any other investigational agent within the last month prior to entry to this trial
- Active infections or serious general medical conditions
- Patients with previous malignancies should only be permitted if they have been in a continued state of "no evidence of disease" for at least 5 years with the exception of adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, and basal cell/squamous cell skin cancer
- Known allergy to treatment medication or its excipients and/or to the contrast medium
Key Trial Info
Start Date :
December 29 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2016
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01227551
Start Date
December 29 2011
End Date
April 6 2016
Last Update
July 5 2019
Active Locations (10)
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1
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
2
St Mary's Medical Center
San Francisco, California, United States, 94117
3
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
4
Rush University Medical Center
Chicago, Illinois, United States, 60612