CPG 7909 Injection in Melanoma - Tabular View

Tracking Information

First Received Date ^ICMJE

October 6, 2003

Last Updated Date

February 9, 2009

Start Date ^ICMJE

December 2003

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria. [ Time Frame: indeterminate ] [ Designated as safety issue: No ]
Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II. [ Time Frame: Indeterminate ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Phase II: assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria
Phase III: evaluate and compare the survival time of the two treatment groups, as selected in Phase II, to DTIC alone
Efficacy
Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations

Change History

Complete list of historical versions of study NCT00070642 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Phase III: Assess the overall response rate [ Time Frame: indeterminate ] [ Designated as safety issue: No ]
Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease. [ Time Frame: indeterminate ] [ Designated as safety issue: No ]
Determine the duration of response. [ Time Frame: indeterminate ] [ Designated as safety issue: No ]
Determine the time to progression [ Time Frame: indeterminate ] [ Designated as safety issue: No ]
Assess the pharmacokinetic profile and immunopharmacodynamic response to CPG 7909 Injection alone or in combination with DTIC, or DTIC alone (immunopharmacodynamic response only). [ Time Frame: indeterminate ] [ Designated as safety issue: No ]
Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone [ Time Frame: indeterminate ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Secondary Efficacy
-overall response rate (complete plus partial responses) according to the RECIST criteria (in Phase III)
-degree of clinical benefit defined as the proportion of patients experiencing complete response,partial responses, stable disease
-duration of response
-time to progression
-pharmacokinetic profile and immunopharmacodynamic response

Descriptive Information

Brief Title ^ICMJE

CPG 7909 Injection in Melanoma

Official Title ^ICMJE

ProMune™ (CPG 7909 Injection) With or Without Chemotherapy for the Treatment of Stage III b/c or IV Melanoma: A Randomized, Multi-Center, Open Label, Parallel Group, Active-Controlled, Phase II/III Study

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Carcinoma, Melanoma

Intervention ^ICMJE

Drug: CPG 7909 Injection
Drug: dacarbazine
Drug: Chemotherapy

Study Arms / Comparison Groups

Experimental: CPG 7909 Injection plus DTIC
Active Comparator: dacarbazine

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

184

Completion Date

December 2005

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00070642

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

C023, CO23, A8501023

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP