CPG 7909 Injection in Melanoma

Phase 2

Completed

• Conditions: Carcinoma, Melanoma
• Interventions: Drug: CPG 7909 Injection; Drug: Chemotherapy; Drug: dacarbazine

• Registration Number: NCT00070642
• Lead Sponsor: Pfizer

Brief Summary

To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-10-06
• Study First Submitted QC: 2003-10-07
• Study First Posted: 2003-10-08
• Study Start: 2003-12
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-09
• Last Update Posted: 2009-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• Histologically or cytologically confirmed melanoma that is metastatic.
• Measurable disease according to the RECIST criteria.
• Karnofsky Performance Status of > 70.

Exclusion Criteria

• Prior treatment with anti-neoplastic biologic or chemotherapy for recurrent or metastatic disease (except one course of adjuvant immunotherapy and/or adjuvant chemotherapy other than DTIC).
• Suspected or known CNS metastases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPG 7909 Injection plus chemotherapy	CPG 7909 Injection	CPG 7909 Injection plus DTIC
CPG 7909 Injection plus chemotherapy	dacarbazine	CPG 7909 Injection plus DTIC
Chemotherapy alone	Chemotherapy	dacarbazine
CPG 7909 Injection 10 mg	CPG 7909 Injection	-
CPG 7909 Injection 40 mg	CPG 7909 Injection	-

Primary Outcome Measures

Name	Time	Method
Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria.	indeterminate
Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II.	Indeterminate

Secondary Outcome Measures

Name	Time	Method
Phase III: Assess the overall response rate	indeterminate
Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease.	indeterminate
Determine the duration of response.	indeterminate
Determine the time to progression	indeterminate
Assess the pharmacokinetic profile and immunopharmacodynamic response to CPG 7909 Injection alone or in combination with DTIC, or DTIC alone (immunopharmacodynamic response only).	indeterminate
Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone	indeterminate