Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT00675727
Status:
TERMINATED
Last Update Posted:
2009-06-11
First Post:
2008-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of CADI-05 in Patients With Advanced Stage Melanoma
Sponsor:
Cadila Pharnmaceuticals
Organization:
Study Overview
Official Title:
Open Label, Single Arm, Phase I/II Study of CADI-05 in Patients With Advanced Stage III or Stage IV Melanoma
Status:
TERMINATED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DSMB reviewed data of 1st 10 subjects; determined no safety concerns. Efficacy as a single agent in this patient population was unlikely. Voluntary Termination
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study examines the safety of treating patients with advanced stage melanoma with the vaccine CADI-05. In addition, preliminary data regarding the clinical response and immune response will be collected.
Detailed Description:
Because there are no highly effective treatment options for patients with advanced, unresectable melanoma, participation in clinical trials of novel therapies is frequently the best therapeutic alternative. CADI-05 is a promising agent for two reasons. First, patients with advanced melanoma frequently have disturbing symptoms such as anorexia with associated weight loss, fatigue, and chemotherapy-associated side effects such as nausea and vomiting. CADI-05 not only has a very low side effect profile, but it actually improves such symptoms. Second, melanomas are generally immunogenic, and sometimes patients mount significant of immune responses to cause spontaneous regression of tumors. High-dose interleukin-2, a relatively toxic therapy that stimulates the immune system, causes long-term regression in stage IV melanoma in a small percentage of patients. In addition, when combined with adoptive immunotherapy, response rates as high as 50% have been observed. Therefore, induction of potent antitumor immune responses in melanoma can be a highly effective therapeutic modality. Because CADI-05 has potent immunostimulatory effects and an excellent side effect profile, it is a very attractive option for treatment of stage IV melanoma patients. Preliminary data from ongoing preclinical studies in a murine melanoma model have shown that CADI-05 has significant biological activity in metastatic melanoma (G. Robertson, unpublished data).
Although it is possible that CADI-05 as a single agent will have activity in advanced melanoma, it may also be useful in conjunction with other systemic agents or as an adjuvant in conjunction with immunotherapy regimens. In addition, previous human trials suggest that CADI-05 may be helpful in symptom control and improvement of quality of life in patients with advanced melanoma. In spite of the promising data from a number of preclinical and clinical studies of this agent, no U.S. studies of the effects of CADI-05 in cancer patients have been performed. Therefore, the present research study proposes to evaluate the safety of CADI-05 treatment in advanced melanoma. In addition, preliminary data regarding the clinical response rate and immune response will be collected.
Although it is possible that CADI-05 as a single agent will have activity in advanced melanoma, it may also be useful in conjunction with other systemic agents or as an adjuvant in conjunction with immunotherapy regimens. In addition, previous human trials suggest that CADI-05 may be helpful in symptom control and improvement of quality of life in patients with advanced melanoma. In spite of the promising data from a number of preclinical and clinical studies of this agent, no U.S. studies of the effects of CADI-05 in cancer patients have been performed. Therefore, the present research study proposes to evaluate the safety of CADI-05 treatment in advanced melanoma. In addition, preliminary data regarding the clinical response rate and immune response will be collected.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: